Devices, systems and methods for heart valve replacement

ABSTRACT

Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include a valve support having an upstream end and a downstream end extending around a longitudinal axis and having a cross-sectional shape. The valve support can have an outer surface and an inner surface, wherein the inner surface is configured to support a prosthetic valve. The device can also include an expandable retainer coupled to the upstream end of the valve support. The retainer can be configured to engage tissue on or near the annulus. In some embodiments, the valve support is mechanically isolated from the retainer such that the cross-sectional shape of the valve support remains sufficiently stable when the retainer is deformed in a non-circular shape by engagement with the tissue.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application claims priority to U.S. patent application Ser.No. 14/352,964, filed Jun. 27, 2014, now allowed, which claims priorityto U.S. Provisional Patent Application No. 61/549,037, filed Oct. 19,2011, entitled “SYSTEM FOR MITRAL VALVE REPLACEMENT,” the disclosures ofwhich are incorporated hereby reference in their entirety.

The present application also incorporates the subject matter of (1)International Patent Application No. PCT/US2012/043636, entitled“PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS,”filed Jun. 21, 2012; (2) U.S. Provisional Patent Application No.61/605,699, filed Mar. 1, 2012, entitled “SYSTEM FOR MITRAL VALVEREPLACEMENT”; (3) U.S. Provisional Patent Application No. 61/549,044,filed Oct. 19, 2011, and entitled “CONFORMABLE SYSTEM FOR MITRAL VALVEREPLACEMENT”; and (4) International Patent Application No.PCT/US2012/061219, entitled “PROSTHETIC HEART VALVE DEVICES, PROSTHETICMITRAL VAVLES AND ASSOCIATED SYSTEMS AND METHODS,” filed Oct. 19, 2012,in their entireties by reference.

TECHNICAL FIELD

The present technology relates generally to prosthetic heart valvedevices. In particular, several embodiments are directed to prostheticmitral valves and devices for percutaneous repair and/or replacement ofnative heart valves and associated systems and methods.

BACKGROUND

Conditions affecting the proper functioning of the mitral valve include,for example, mitral valve regurgitation, mitral valve prolapse andmitral valve stenosis. Mitral valve regurgitation is a disorder of theheart in which the leaflets of the mitral valve fail to coapt intoapposition at peak contraction pressures, resulting in abnormal leakingof blood from the left ventricle into the left atrium. There are anumber of structural factors that may affect the proper closure of themitral valve leaflets. For example, many patients suffering from heartdisease experience dilation of the heart muscle, resulting in anenlarged mitral annulus. Enlargement of the mitral annulus makes itdifficult for the leaflets to coapt during systole. A stretch or tear inthe chordae tendineae, the tendons connecting the papillary muscles tothe inferior side of the mitral valve leaflets, may also affect properclosure of the mitral annulus. A ruptured chordae tendineae, forexample, may cause a valve leaflet to prolapse into the left atrium dueto inadequate tension on the leaflet. Abnormal backflow can also occurwhen the functioning of the papillary muscles is compromised, forexample, due to ischemia. As the left ventricle contracts duringsystole, the affected papillary muscles do not contract sufficiently toeffect proper closure.

Mitral valve prolapse, or when the mitral leaflets bulge abnormally upin to the left atrium, causes irregular behavior of the mitral valve andmay also lead to mitral valve regurgitation. Normal functioning of themitral valve may also be affected by mitral valve stenosis, or anarrowing of the mitral valve orifice, which causes impedance of fillingof the left ventricle in diastole.

Typically, treatment for mitral valve regurgitation has involved theapplication of diuretics and/or vasodilators to reduce the amount ofblood flowing back into the left atrium. Other procedures have involvedsurgical approaches (open and intravascular) for either the repair orreplacement of the valve. For example, typical repair approaches haveinvolved cinching or resecting portions of the dilated annulus.

Cinching of the annulus has been accomplished by the implantation ofannular or pen-annular rings which are generally secured to the annulusor surrounding tissue. Other repair procedures have also involvedsuturing or clipping of the valve leaflets into partial apposition withone another.

Alternatively, more invasive procedures have involved the replacement ofthe entire valve itself where mechanical valves or biological tissue areimplanted into the heart in place of the mitral valve. These areconventionally done through large open thoracotomies and are thus verypainful, have significant morbidity, and require long recovery periods.

However, with many repair and replacement procedures the durability ofthe devices or improper sizing of annuloplasty rings or replacementvalves may result in additional problems for the patient. Moreover, manyof the repair procedures are highly dependent upon the skill of thecardiac surgeon where poorly or inaccurately placed sutures may affectthe success of procedures.

Less invasive approaches to aortic valve replacement have been developedin recent years. Examples of pre-assembled, percutaneous prostheticvalves include, e.g., the CoreValve Revalving® System fromMedtronic/Corevalve Inc. (Irvine, Calif., USA) the Edwards-Sapien® Valvefrom Edwards Lifesciences (Irvine, Calif., USA). Both valve systemsinclude an expandable frame housing a tri-leaflet bioprosthetic valve.The frame is expanded to fit the substantially symmetric circular aorticvalve. This gives the expandable frame in the delivery configuration asymmetric, circular shape at the aortic valve annulus, perfectlyfunctional to support a tri-leaflet prosthetic valve (which requiressuch symmetry for proper coaptation of the prosthetic leaflets). Thus,aortic valve anatomy lends itself to an expandable frame housing areplacement valve since the aortic valve anatomy is substantiallyuniform and symmetric. The mitral valve, on the other hand, is generallyD-shaped and not symmetric, meaning that expansion of the CoreValve andSapien systems in the mitral valve renders such systems non-functional.For example, in both systems the frame both anchors (or helps to anchor)and provides shape to the replacement valve within. If the frame isflexible enough to assume the asymmetric shape of the mitral valve, thenthe attached tri-leaflet replacement valve will also be similarlyshaped, making it almost impossible for the leaflets to coapt properlyand thus allowing leaks. Additionally, if the frame is so rigid that itremains symmetric, the outer diameter of the frame will not be able tocover the commissures of the mitral valve, also allowing leaks.

In addition, mitral valve replacement, compared with aortic valvereplacement, poses unique anatomical obstacles, rendering percutaneousmitral valve replacement significantly more involved and challengingthan aortic valve replacement. First, unlike the relatively symmetricand uniform aortic valve, the mitral valve annulus has a non-circularD-shape or kidney-like shape and may be of unpredictable geometry, oftentimes lacking symmetry. Such unpredictability makes it difficult todesign a mitral valve prosthesis having the ability to conform to themitral annulus. Lack of a snug fit between the leaflets and/or annulusand the prosthesis leaves gaps therein, creating backflow of bloodthrough these gaps. Placement of a cylindrical valve prosthesis, forexample, may leave gaps in commissural regions of the native valve,potentially resulting in perivalvular leaks in those regions.

Current devices seeking to overcome the large and irregular shape of themitral valve have several drawbacks. First, many of the devices todayhave a direct, structural connection between the device structure whichcontacts the annulus and/or leaflets and the device structure whichsupports the prosthetic valve. In several devices, the same stent postswhich support the prosthetic valve also contact subannular tissue,directly transferring many of the distorting forces present in theheart, for example, systolic pressure, diastolic pressure, compressiveintra-annular forces, etc., causing hoop stress in the stent portionsurrounding the prosthetic valve. Most cardiac replacement devicesutilize a tri-leaflet valve, which requires a substantially symmetric,cylindrical support around the prosthetic valve for proper opening andclosing of the three leaflets. Devices which provide a direct,mechanical connection between annular and/or leaflet distorting forcesand the prosthetic valve may compress and/or distort the symmetrical,cylindrical structure surrounding the prosthetic valve causing theprosthetic leaflets to malfunction.

In addition to its irregular, unpredictable shape, the mitral valveannulus lacks a significant amount of radial support from surroundingtissue. The aortic valve, for example, is completely surrounded byfibro-elastic tissue, helping to anchor a prosthetic valve by providingnative structural support. The mitral valve, on the other hand, is boundby muscular tissue on the outer wall only. The inner wall of the mitralvalve is bound by a thin vessel wall separating the mitral valve annulusfrom the inferior portion of the aortic outflow tract. As a result,significant radial forces on the mitral annulus, such as that impartedby expanding stent prostheses, could lead to collapse of the inferiorportion of the aortic tract with potentially fatal consequences.

The chordae tendineae of the left ventricle may also present an obstaclein deploying a mitral valve prosthesis. This is unique to the mitralvalve since aortic valve anatomy does not include chordae. The maze ofchordae in the left ventricle makes navigating and positioning adeployment catheter more difficult in mitral valve replacement andrepair. Deployment and positioning of a prosthetic valve or anchoringdevice on the ventricular side of the native valve is also complicatedby the presence of the chordae.

Given the difficulties associated with current procedures, there remainsthe need for simple, effective, and less invasive devices and methodsfor treating dysfunctional heart valves.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent.

FIGS. 1 and 2 are schematic illustrations of a mammalian heart havingnative valve structures suitable for replacement with various prostheticheart valve devices in accordance with embodiments of the presenttechnology.

FIG. 3 is a schematic cross-sectional side view of a native mitral valveshowing the annulus and leaflets.

FIG. 4A is a schematic illustration of the left ventricle of a hearthaving either i) prolapsed leaflets in the mitral valve, or ii) mitralvalve regurgitation in the left ventricle of a heart having impairedpapillary muscles, and which are suitable for combination with variousprosthetic heart valve devices in accordance with embodiments of thepresent technology.

FIG. 4B is a schematic illustration of a heart in a patient sufferingfrom cardiomyopathy, and which is suitable for combination with variousprosthetic heart valve devices in accordance with embodiments of thepresent technology.

FIG. 5A is a schematic illustration of a native mitral valve of a heartshowing normal closure of native mitral valve leaflets.

FIG. 5B is a schematic illustration of a native mitral valve of a heartshowing abnormal closure of native mitral valve leaflets in a dilatedheart, and which is suitable for combination with various prostheticheart valve devices in accordance with embodiments of the presenttechnology.

FIG. 5C is a schematic illustration of a mitral valve of a heart showingdimensions of the annulus, and which is suitable for combination withvarious prosthetic heart valve devices in accordance with embodiments ofthe present technology.

FIG. 6A is a schematic, cross-sectional illustration of the heartshowing an antegrade approach to the native mitral valve from the venousvasculature in accordance with various embodiments of the presenttechnology.

FIG. 6B is a schematic, cross-sectional illustration of the heartshowing access through the inter-atrial septum (IAS) maintained by theplacement of a guide catheter over a guidewire in accordance withvarious embodiments of the present technology.

FIGS. 7 and 8 are schematic, cross-sectional illustrations of the heartshowing retrograde approaches to the native mitral valve through theaortic valve and arterial vasculature in accordance with variousembodiments of the present technology.

FIG. 9 is a schematic, cross-sectional illustration of the heart showingan approach to the native mitral valve using a trans-apical puncture inaccordance with various embodiments of the present technology.

FIG. 10A shows an isometric view of a prosthetic heart valve device inaccordance with an embodiment of the present technology.

FIG. 10B illustrates a cut-away view of a heart showing the prostheticheart valve device of FIG. 10A implanted at a native mitral valve inaccordance with an embodiment of the present technology.

FIGS. 10C-10D are side and top views, respectively, of a prostheticheart valve device in accordance with an embodiment of the presenttechnology.

FIG. 11 is an isometric view of a valve support with a prosthetic valvemounted therein in accordance with an embodiment of the presenttechnology.

FIGS. 12A-12H are side views of various mechanisms of coupling a valvesupport to a retainer in accordance with additional embodiments of thepresent technology.

FIGS. 13A-13G are partial side views of a variety of flexible ribconfigurations in accordance with additional embodiments of the presenttechnology.

FIGS. 14A-14J are side views of various flexible ribs flexing inresponse to a distorting force in accordance with further embodiments ofthe present technology.

FIGS. 15A-15E are schematic top views of the prosthetic heart valvedevice showing a variety of rib configurations in accordance withfurther embodiments of the present technology.

FIGS. 16A-16B are schematic side and cross-sectional views of theprosthetic heart valve device showing additional embodiments of theretainer in accordance with the present technology.

FIG. 17A is a schematic top view of a native mitral valve illustratingthe major and minor axes.

FIGS. 17B-17C are schematic top views of a retainer in an expandedconfiguration and in a deployed configuration, respectively, inaccordance with an embodiment of the present technology.

FIG. 18 is a side view of a prosthetic heart valve device shown in anexpanded configuration in accordance with a further embodiment of thepresent technology.

FIG. 19 is an isometric view of the prosthetic heart valve device havinga connecting ring in accordance with an embodiment of the presenttechnology.

FIGS. 20A-20B are isometric views of a retainer support ring and theprosthetic heart valve device having the retainer support ring inaccordance with an additional embodiment of the present technology.

FIG. 21 is an isometric view of a prosthetic heart valve device in anexpanded configuration and having a plurality of stabilizing elements inaccordance with an embodiment of the present technology.

FIG. 22 is an enlarged schematic, side view of a prosthetic heart valvedevice having an extended arm in accordance with an embodiment of thepresent technology.

FIGS. 23A-23C are enlarged partial side views of a prosthetic heartvalve device having arms coupled to the device at various angles withrespect to a longitudinal axis of the device in accordance with furtherembodiments of the present technology.

FIGS. 24A-24C are enlarged, partial side views of a prosthetic heartvalve device having arms of various lengths coupled to the device inaccordance with additional embodiments of the present technology.

FIGS. 25A-25E are cross-sectional views of a heart with an implantedprosthetic heart valve device having arms disposed on an inward-facingsurface of the leaflets in accordance with various embodiments of thepresent technology.

FIGS. 26A-26C are schematic views illustrating various embodiments oftissue engaging elements for use with prosthetic heart valve devices inaccordance with the present technology.

FIGS. 27A-27C are enlarged, partial side views of a prosthetic heartvalve device having arms with tissue engaging elements configured toengage an inward-facing surface of the leaflets in accordance withvarious embodiments of the present technology.

FIGS. 28A-28B are side views showing prosthetic heart valve devicesimplanted at a mitral valve MV (illustrated in cross-section) in adeployed configuration, wherein the devices have arms for engaging anoutward-facing surface of the native leaflets in accordance with furtherembodiments of the present technology.

FIG. 28C is an enlarged, partial side view of a prosthetic heart valvedevice having an arm with tissue engaging elements configured to engagean outward-facing surface of the leaflets in accordance with anotherembodiment of the present technology.

FIG. 29A is a side view of a prosthetic heart valve device and shownimplanted at a mitral valve (illustrated in cross-section), the devicehaving arms for engaging an outward-facing surface of the nativeleaflets and arms for engaging an inward-facing surface of the nativeleaflets in accordance with an additional embodiment of the presenttechnology.

FIG. 29B is an enlarged view of the arms engaging the inward-facing andoutward-facing surfaces of the leaflets as shown in FIG. 29A.

FIGS. 30A and 30C are isometric views of the prosthetic heart valvedevice having arms with a similar profile as a profile of the retainerin accordance with additional embodiments of the present technology.

FIGS. 30B and 30D are side views of the prosthetic heart valve devicesof FIGS. 30A and 30C, respectively, and shown implanted at a mitralvalve (illustrated in cross-section) in accordance with the presenttechnology.

FIG. 31A is a side view of a prosthetic heart valve device having aplurality of non-interconnected arms in accordance with a furtherembodiment of the present technology.

FIG. 31B is a side view of a prosthetic heart valve device having aplurality of circumferentially connected arms in accordance with afurther embodiment of the present technology.

FIGS. 32A-32D are schematic top views of arm location patterns inaccordance with additional embodiments of the present technology.

FIGS. 33A-33E are side views of prosthetic heart valve devices havingtissue engaging elements on varying structures of the device inaccordance with additional embodiments of the present technology.

FIGS. 33E-33G are enlarged side views of tissue engaging elementssuitable for use with prosthetic heart valve devices in accordance withother embodiments of the present technology.

FIGS. 34A-34B are an isometric view and an enlarged detail view of aprosthetic heart valve device having a sealing member configured withtissue engaging elements in accordance with another embodiment of thepresent technology.

FIGS. 35A-35F are enlarged side views of embodiments of tissue engagingelements suitable for use with prosthetic heart valve devices inaccordance with additional embodiments of the present technology.

FIG. 36A is an isometric view of a prosthetic heart valve device 100having an atrial extension member 410 in accordance with variousembodiments of the present technology.

FIGS. 36B-36C are schematic, top views of an embodiment of a prostheticheart valve device having an atrial extension member without (FIG. 36B)and with (FIG. 36C) a twisting force applied to the device in accordancewith the present technology.

FIG. 37A is side partial cut-away view of a delivery system inaccordance with an embodiment of the present technology.

FIG. 37B is an enlarged cross-sectional view of a distal end of adelivery system in accordance with an embodiment of the presenttechnology.

FIGS. 37C-37D are enlarged partial side views of a valve supportconfigured for use with the delivery system of FIG. 37B in accordancewith an embodiment of the present technology.

FIGS. 38A-38D are cross-sectional views of a heart showing an antegradeor trans-septal approach to the mitral valve in accordance with anembodiment of the present technology.

FIGS. 39A-39C are cross-sectional views of the heart illustrating amethod of implanting a prosthetic heart valve device using atrans-septal approach in accordance with another embodiment of thepresent technology.

FIGS. 40A-40C are cross-sectional views of the heart illustrating afurther embodiment of a method of implanting the prosthetic heart valvedevice using a trans-apical approach in accordance with aspects of thepresent technology.

DETAILED DESCRIPTION

Specific details of several embodiments of the technology are describedbelow with reference to FIGS. 1-40C. Although many of the embodimentsare described below with respect to devices, systems, and methods forpercutaneous replacement of a native mitral valve using prosthetic valvedevices, other applications and other embodiments in addition to thosedescribed herein are within the scope of the technology. Additionally,several other embodiments of the technology can have differentconfigurations, components, or procedures than those described herein. Aperson of ordinary skill in the art, therefore, will accordinglyunderstand that the technology can have other embodiments withadditional elements, or the technology can have other embodimentswithout several of the features shown and described below with referenceto FIGS. 1-40C.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can reference arelative position of the portions of a prosthetic valve device and/or anassociated delivery device with reference to an operator and/or alocation in the vasculature or heart. For example, in referring to adelivery catheter suitable to deliver and position various prostheticvalve devices described herein, “proximal” can refer to a positioncloser to the operator of the device or an incision into thevasculature, and “distal” can refer to a position that is more distantfrom the operator of the device or further from the incision along thevasculature (e.g., the end of the catheter). With respect to aprosthetic heart valve device, the terms “proximal” and “distal” canrefer to the location of portions of the device with respect to thedirection of blood flow. For example, proximal can refer to an upstreamposition or a position of blood inflow, and distal can refer to adownstream position or a position of blood outflow. For ease ofreference, throughout this disclosure identical reference numbers and/orletters are used to identify similar or analogous components orfeatures, but the use of the same reference number does not imply thatthe parts should be construed to be identical. Indeed, in many examplesdescribed herein, the identically numbered parts are distinct instructure and/or function. The headings provided herein are forconvenience only.

Overview

Systems, devices and methods are provided herein for percutaneousreplacement of native heart valves, such as mitral valves. Several ofthe details set forth below are provided to describe the followingexamples and methods in a manner sufficient to enable a person skilledin the relevant art to practice, make and use them. Several of thedetails and advantages described below, however, may not be necessary topractice certain examples and methods of the technology. Additionally,the technology may include other examples and methods that are withinthe scope of the claims but are not described in detail.

Embodiments of the present technology provide systems, methods andapparatus to treat valves of the body, such as heart valves includingthe mitral valve. The apparatus and methods enable a percutaneousapproach using a catheter delivered intravascularly through a vein orartery into the heart. Additionally, the apparatus and methods enableother less-invasive approaches including trans-apical, trans-atrial, anddirect aortic delivery of a prosthetic replacement valve to a targetlocation in the heart. The apparatus and methods enable a prostheticdevice to be anchored at a native valve location by engagement with asubannular surface of the valve annulus and/or valve leaflets.Additionally, the embodiments of the devices and methods as describedherein can be combined with many known surgeries and procedures, forexample combined with known methods of accessing the valves of the heartsuch as the mitral valve or triscuspid valve with antegrade orretrograde approaches, and combinations thereof.

The devices and methods described herein provide a valve replacementdevice that has the flexibility to adapt and conform to thevariably-shaped native mitral valve anatomy while mechanically isolatingthe prosthetic valve from the anchoring portion of the device, which canabsorb the distorting forces applied by the native anatomy. The devicehas the structural strength and integrity necessary to withstand thedynamic conditions of the heart over time, thus permanently anchoring areplacement valve and making it possible for the patient to resume asubstantially normal life. The devices and methods further deliver sucha device in a less-invasive manner, providing a patient with a new,permanent replacement valve but also with a lower-risk procedure and afaster recovery.

The devices and methods described herein provide a valve replacementdevice that has the flexibility to adapt and conform to thevariably-shaped native mitral valve anatomy while simultaneouslyproviding the structural strength and integrity necessary to withstandthe dynamic conditions of the heart over time, thus permanentlyanchoring a replacement valve, making it possible for the patient toresume a substantially normal life. The devices and methods furtherdeliver such a device in a less-invasive manner, providing a patientwith a new, permanent replacement valve but also with a lower-riskprocedure and a faster recovery.

In accordance with various embodiments of the present technology, adevice for repair or replacement of a native heart valve, wherein thenative heart valve has an annulus and leaflets coupled to the annulus isdisclosed. The device can include a valve support having an upstream endand a downstream end extending around a longitudinal axis, and have anouter surface and an inner surface. The valve support can have across-sectional shape and the inner surface can be configured to supporta prosthetic valve. The device can also include an expandable retainerthat is couple dot the upstream end of the valve support. The retainercan be configured to engage tissue on or downstream of the annulus. Invarious embodiments, the valve support is mechanically isolated from theretainer such that the cross-sectional shape of the valve supportremains sufficiently stable when the retainer is deformed in anon-circular shape by engagement with the tissue.

Some embodiments of the disclosure are directed to prosthetic heartvalve devices for treating a mitral valve. The device can include avalve support configured to support a valve. The device can also includea retainer coupled to the valve support and positionable at leastpartially along a subannular surface of a native mitral valve annulus.The retainer can also inhibit upstream migration of the device. Theretainer is coupled to the valve support so as to mechanically isolatethe valve support from distorting force exerted on the retainer bynative anatomy.

In some embodiments, the device may comprise an atrial extension memberextending from the retainer to a position at least partially upstream ofthe native mitral annulus. In other embodiments, the device may furthercomprise a plurality of arms extending radially outward from the valvesupport. The arms can be configured to engage native leaflets of themitral valve, for example. Some embodiments of the device may furthercomprise one or more stabilizing members for engaging subannular tissueand limiting movement of the device in an upstream or downstreamdirection.

In a further embodiment, a prosthetic heart valve device for treating amitral valve can include an expandable retainer configured to engagecardiac tissue at or downstream of a native mitral valve annulus. Thedevice can also include a valve support coupled to and at leastpartially surrounded by the expandable retainer. The valve support canbe configured to support a prosthetic valve such as either a temporaryvalve, or in other embodiments, a permanent valve structure. In thesearrangements, the expandable retainer is configured to conform to theshape of the native mitral valve annulus while the valve support remainssubstantially unchanged.

In yet a further embodiment, a prosthetic heart valve device fortreating a heart valve in a patient can include a valve support having agenerally circular shape and configured to support a prosthetic valve,and a deformable retainer coupled to an upstream portion of the valvesupport. The deformable retainer can be configured to engage cardiactissue on or below an annulus of the heart valve. The valve support canbe mechanically isolated from the retainer such that deformation of theretainer does not substantially affect the generally circular shape ofthe valve support. The device may also include a plurality of armscoupled to a downstream portion of the valve support. The arms can bebiased outward from the valve support in an unbiased configuration suchthat the plurality of arms can be configured to engage a native mitralleaflet.

The disclosure further provides systems for delivery of prostheticvalves and other devices using endovascular or other minimally invasiveforms of access. For example, embodiments of the present technologyprovide a system to treat a mitral valve of a patient, in which themitral valve has an annulus. The system comprises a device to treat themitral valve as described herein and a catheter having a lumenconfigured to retain the device within the catheter.

In yet another aspect, embodiments of the present technology provide amethod of treating a heart valve of a patient. The mitral valve has anannulus and leaflets coupled to the annulus. The method can includeimplanting a device as described herein within or adjacent to theannulus. The device, in some embodiments, can include a valve supportcoupled to and at least partially surrounded by a deformable retainer.The deformable retainer can be coupled to an upstream end of the valvesupport. The deformable retainer can be disposed between the leafletsand be configured to engage tissue on or near the annulus to preventmigration of the device in an upstream direction. Further, the valvesupport can be mechanically isolated from the deformable retainer suchthat a cross-sectional shape of the valve support does not substantiallychange if the retainer is deformed by engagement with the tissue.

In yet a further aspect, embodiments of the present technology provide amethod for replacement of a native heart valve having an annulus and aplurality of leaflets. The method can include positioning a prostheticdevice as described herein between the leaflets, while the device is ina collapsed configuration. The method can also include allowing theprosthetic device to expand such that a retainer of the prostheticdevice is in a subannular position in which it engages tissue on ordownstream of the annulus. The retainer can have a diameter larger thana corresponding diameter of the annulus in the subannular position. Themethod can further include allowing a valve support to expand within theretainer, wherein the valve support is coupled to the retainer at anupstream end of the valve support. In various embodiments, the valvesupport can be mechanically isolated from the retainer such thatdeformation of the retainer when the retainer engages the tissue doesnot substantially deform the valve support.

The devices and methods disclosed herein can be configured for treatingnon-circular, asymmetrically shaped valves and bileaflet or bicuspidvalves, such as the mitral valve. Many of the devices and methodsdisclosed herein can further provide for long-term (e.g., permanent) andreliable anchoring of the prosthetic device even in conditions where theheart or native valve may experience gradual enlargement or distortion.

Cardiac and Mitral Valve Physiology

FIGS. 1 and 2 show a normal heart H. The heart comprises a left atriumthat receives oxygenated blood from the lungs via the pulmonary veins PVand pumps this oxygenated blood through the mitral valve MV into theleft ventricle LV. The left ventricle LV of a normal heart H in systoleis illustrated in FIG. 2. The left ventricle LV is contracting and bloodflows outwardly through the aortic valve AV in the direction of thearrows. Back flow of blood or “regurgitation” through the mitral valveMV is prevented since the mitral valve is configured as a “check valve”which prevents back flow when pressure in the left ventricle is higherthan that in the left atrium LA.

The mitral valve MV comprises a pair of leaflets having free edges FEwhich meet evenly, or “coapt” to close, as illustrated in FIG. 2. Theopposite ends of the leaflets LF are attached to the surrounding heartstructure via an annular region of tissue referred to as the annulus AN.FIG. 3 is a schematic cross-sectional side view of an annulus andleaflets of a mitral valve. As illustrated, the opposite ends of theleaflets LF are attached to the surrounding heart structure via afibrous ring of dense connective tissue referred to as the annulus AN,which is distinct from both the leaflet tissue LF as well as theadjoining muscular tissue of the heart wall. The leaflets LF and annulusAN are comprised of different types of cardiac tissue having varyingstrength, toughness, fibrosity, and flexibility. Furthermore, the mitralvalve MV may also comprise a unique region of tissue interconnectingeach leaflet LF to the annulus AN, referred to herein as leaflet/annulusconnecting tissue LAC (indicated by overlapping cross-hatching). Ingeneral, annular tissue AN is tougher, more fibrous, and stronger thanleaflet tissue LF.

Referring to FIG. 2, the free edges FE of the mitral leaflets LF aresecured to the lower portions of the left ventricle LV through chordaetendineae CT (referred to hereinafter “chordae”) which include aplurality of branching tendons secured over the lower surfaces of eachof the valve leaflets LF. The chordae CT in turn, are attached to thepapillary muscles PM, which extend upwardly from the lower wall of theleft ventricle LV and interventricular septum IVS.

Referring now to FIGS. 4A to 4B, a number of structural defects in theheart can cause mitral valve regurgitation. Ruptured chordae RCT, asshown in FIG. 4A, can cause a valve leaflet LF2 to prolapse sinceinadequate tension is transmitted to the leaflet via the chordae. Whilethe other leaflet LF1 maintains a normal profile, the two valve leafletsdo not properly meet and leakage from the left ventricle LV into theleft atrium LA will occur, as shown by the arrow.

Regurgitation also occurs in the patients suffering from cardiomyopathywhere the heart is dilated and the increased size prevents the valveleaflets LF from meeting properly, as shown in FIG. 4B. The enlargementof the heart causes the mitral annulus to become enlarged, making itimpossible for the free edges FE to meet during systole. The free edgesof the anterior and posterior leaflets normally meet along a line ofcoaptation C as shown in FIG. 5A, but a significant gap G can be left inpatients suffering from cardiomyopathy, as shown in FIG. 5B.

Mitral valve regurgitation can also occur in patients who have sufferedischemic heart disease where the functioning of the papillary muscles PMis impaired, as illustrated in FIG. 4A. As the left ventricle LVcontracts during systole, the papillary muscles PM do not contractsufficiently to effect proper closure. One or both of the leaflets LF1and LF2 then prolapse. Leakage again occurs from the left ventricle LVto the left atrium LA.

FIGS. 5A-5C further illustrate the shape and relative sizes of theleaflets L of the mitral valve. Referring to FIG. 5C, it may be seenthat the overall valve has a generally “D”—or kidney-like shape, with along axis MVA1 and a short axis MVA2. In healthy humans the long axisMVA1 is typically within a range from about 33.3 mm to about 42.5 mm inlength (37.9+/−4.6 mm), and the short axis MVA2 is within a range fromabout 26.9 to about 38.1 mm in length (32.5+/−5.6 mm). However, withpatients having decreased cardiac function these values can be larger,for example MVA1 can be within a range from about 45 mm to 55 mm andMVA2 can be within a range from about 35 mm to about 40 mm. The line ofcoaptation C is curved or C-shaped, thereby defining a relatively largeanterior leaflet AL and substantially smaller posterior leaflet PL (FIG.5A). Both leaflets appear generally crescent-shaped from the superior oratrial side, with the anterior leaflet AL being substantially wider inthe middle of the valve than the posterior leaflet. As illustrated inFIG. 5A, at the opposing ends of the line of coaptation C the leafletsjoin together at corners called the anterolateral commissure AC andposteromedial commissure PC, respectively.

FIG. 5C shows the shape and dimensions of the annulus of the mitralvalve. The annulus is an annular area around the circumference of thevalve comprised of fibrous tissue which is thicker and tougher than thatof the leaflets LF and distinct from the muscular tissue of theventricular and atrial walls. The annulus may comprise a saddle-likeshape with a first peak portion PP1 and a second peak portion PP2located along an interpeak axis IPD, and a first valley portion VP1 anda second valley portion VP2 located along an intervalley axis IVD. Thefirst and second peak portion PP1 and PP2 are higher in elevationrelative to a plane containing the nadirs of the two valley portionsVP1, VP2, typically being about 8-19 mm higher in humans, thus givingthe valve an overall saddle-like shape. The distance between the firstand second peak portions PP1, PP2, referred to as interpeak span IPD, issubstantially shorter than the intervalley span IVD, the distancebetween first and second valley portions VP1, VP2.

A person of ordinary skill in the art will recognize that the dimensionsand physiology of the patient may vary among patients, and although somepatients may comprise differing physiology, the teachings as describedherein can be adapted for use by many patients having variousconditions, dimensions and shapes of the mitral valve. For example, workin relation to embodiments suggests that some patients may have a longdimension across the annulus and a short dimension across the annuluswithout well-defined peak and valley portions, and the methods anddevice as described herein can be configured accordingly.

Access to the Mitral Valve

Access to the mitral valve or other atrioventricular valve can beaccomplished through the patient's vasculature in a percutaneous manner.By percutaneous it is meant that a location of the vasculature remotefrom the heart is accessed through the skin, typically using a surgicalcut down procedure or a minimally invasive procedure, such as usingneedle access through, for example, the Seldinger technique. The abilityto percutaneously access the remote vasculature is well-known anddescribed in the patient and medical literature. Depending on the pointof vascular access, the approach to the mitral valve may be antegradeand may rely on entry into the left atrium by crossing the inter-atrialseptum. Alternatively, approach to the mitral valve can be retrogradewhere the left ventricle is entered through the aortic valve. Oncepercutaneous access is achieved, the interventional tools and supportingcatheter(s) may be advanced to the heart intravascularly and positionedadjacent the target cardiac valve in a variety of manners, as describedherein.

Using a trans-septal approach, access is obtained via the inferior venacava IVC or superior vena cava SVC, through the right atrium RA, acrossthe inter-atrial septum IAS and into the left atrium LA above the mitralvalve MV.

As shown in FIG. 6A, a catheter 1 having a needle 2 may be advanced fromthe inferior vena cava IVC into the right atrium RA. Once the catheter 1reaches the anterior side of the inter-atrial septum IAS, the needle 2may be advanced so that it penetrates through the septum, for example atthe fossa ovalis FO or the foramen ovate into the left atrium LA. Atthis point, a guidewire may be exchanged for the needle 2 and thecatheter 1 withdrawn.

As shown in FIG. 6B, access through the inter-atrial septum IAS mayusually be maintained by the placement of a guide catheter 4, typicallyover a guidewire 6 which has been placed as described above. The guidecatheter 4 affords subsequent access to permit introduction of thedevice to replace the mitral valve, as described in more detail herein.

In an alternative antegrade approach (not shown), surgical access may beobtained through an intercostal incision, preferably without removingribs, and a small puncture or incision may be made in the left atrialwall. A guide catheter may then be placed through this puncture orincision directly into the left atrium, sealed by a purse-string suture.

The antegrade or trans-septal approach to the mitral valve, as describedabove, can be advantageous in many respects. For example, the use of theantegrade approach will usually allow for more precise and effectivecentering and stabilization of the guide catheter and/or prostheticvalve device. Precise positioning facilitates accuracy in the placementof the prosthetic valve device. The antegrade approach may also reducethe risk of damaging the subvalvular device during catheter andinterventional tool introduction and manipulation. Additionally, theantegrade approach may decrease risks associated with crossing theaortic valve as in retrograde approaches. This can be particularlyrelevant to patients with prosthetic aortic valves, which cannot becrossed at all or without substantial risk of damage.

An example of a retrograde approach to the mitral valve is illustratedin FIGS. 7 and 8. The mitral valve MV may be accessed by an approachfrom the aortic arch AA, across the aortic valve AV, and into the leftventricle LV below the mitral valve MV. The aortic arch AA may beaccessed through a conventional femoral artery access route, as well asthrough more direct approaches via the brachial artery, axillary artery,radial artery, or carotid artery. Such access may be achieved with theuse of a guidewire 6. Once in place, a guide catheter 4 may be trackedover the guidewire 6. Alternatively, a surgical approach may be takenthrough an incision in the chest, preferably intercostally withoutremoving ribs, and placing a guide catheter through a puncture in theaorta itself. The guide catheter 4 affords subsequent access to permitplacement of the prosthetic valve device, as described in more detailherein.

In some specific instances, a retrograde arterial approach to the mitralvalve may be choosen due to certain advantages. For example, use of theretrograde approach can eliminate the need for a trans-septal puncture.The retrograde approach is also more commonly used by cardiologists andthus has the advantage of familiarity.

An additional approach to the mitral valve is via trans-apical puncture,as shown in FIG. 9. In this approach, access to the heart is gained viathoracic incision, which can be a conventional open thoracotomy orsternotomy, or a smaller intercostal or sub-xyphoid incision orpuncture. An access cannula is then placed through a puncture, sealed bya purse-string suture, in the wall of the left ventricle at or near theapex of the heart. The catheters and prosthetic devices of the inventionmay then be introduced into the left ventricle through this accesscannula.

The trans-apical approach has the feature of providing a shorter,straighter, and more direct path to the mitral or aortic valve. Further,because it does not involve intravascular access, the trans-apicalprocedure can be performed by surgeons who may not have the necessarytraining in interventional cardiology to perform the catheterizationsrequired in other percutaneous approaches.

The prosthetic treatment device may be specifically designed for theapproach or interchangeable among approaches. A person of ordinary skillin the art can identify an appropriate approach for an individualpatient and design the treatment apparatus for the identified approachin accordance with embodiments described herein.

Orientation and steering of the prosthetic valve device can be combinedwith many known catheters, tools and devices. Such orientation may beaccomplished by gross steering of the device to the desired location andthen refined steering of the device components to achieve a desiredresult.

Gross steering may be accomplished by a number of methods. A steerableguidewire may be used to introduce a guide catheter and the prosthetictreatment device into the proper position. The guide catheter may beintroduced, for example, using a surgical cut down or Seldinger accessto the femoral artery in the patient's groin. After placing a guidewire,the guide catheter may be introduced over the guidewire to the desiredposition. Alternatively, a shorter and differently shaped guide cathetercould be introduced through the other routes described above.

A guide catheter may be pre-shaped to provide a desired orientationrelative to the mitral valve. For access via the trans-septal approach,the guide catheter may have a curved, angled or other suitable shape atits tip to orient the distal end toward the mitral valve from thelocation of the septal puncture through which the guide catheterextends. For the retrograde approach, as shown in FIGS. 7 and 8, guidecatheter 4 may have a pre-shaped J-tip which is configured so that itturns toward the mitral valve MV after it is placed over the aortic archAA and through the aortic valve AV. As shown in FIG. 7, the guidecatheter 4 may be configured to extend down into the left ventricle LVand to assume a J-shaped configuration so that the orientation of aninterventional tool or catheter is more closely aligned with the axis ofthe mitral valve MV. In either case, a pre-shaped guide catheter may beconfigured to be straightened for endovascular delivery by means of astylet or stiff guidewire which is passed through a lumen of the guidecatheter. The guide catheter might also have pull-wires or other meansto adjust its shape for more fine steering adjustment.

Selected Embodiments of Prosthetic Heart Valve Devices and Methods

Embodiments of the present technology as described herein can be used totreat one or more of the valves of the heart as described herein, and inparticular embodiments, can be used for treatment of the mitral valve.Examples of prosthetic heart valve devices, system components andassociated methods in accordance with embodiments of the presenttechnology are described in this section with reference to FIGS.10A-40C. It will be appreciated that specific elements, substructures,advantages, uses, and/or other features of the embodiments describedwith reference to FIGS. 10A-40C can be suitably interchanged,substituted or otherwise configured with one another in accordance withadditional embodiments of the present technology. Furthermore, suitableelements of the embodiments described with reference to FIGS. 10A-40Ccan be used as stand-alone and/or self-contained devices.

Systems, devices and methods are provided herein for percutaneousimplantation of prosthetic heart valves in a heart of a patient. In someembodiments, methods and devices are presented for the treatment ofvalve disease by minimally invasive implantation of artificialreplacement heart valves. In one embodiment, the artificial replacementvalve can be a prosthetic valve device suitable for implantation andreplacement of a mitral valve between the left atrium and left ventriclein the heart of a patient. In another embodiment, the prosthetic valvedevice can be suitable for implantation and replacement of another valve(e.g., a bicuspid or tricuspid valve) in the heart of the patient. FIG.10A shows an isometric view of a prosthetic heart valve device 100 in anexpanded configuration 102 in accordance with an embodiment of thepresent technology, and FIG. 10B is a schematic illustration of across-sectional view of a heart depicting the left atrium, leftventricle, and native mitral valve of the heart. FIG. 10B also shows anembodiment of the expandable prosthetic valve device 100 implanted inthe native mitral valve region of the heart.

As shown in FIG. 10A, the device 100 can include an expandable retainer110 at least partially surrounding and coupled to an inner valve support120. The device 100 can further include a prosthetic valve 130 coupledto, mounted within, or otherwise carried by the valve support 120. FIGS.10C-10D are side and top views, respectively, of the prosthetic heartvalve device 100 in accordance with the present technology. Referring toFIG. 10A, the device 100 can also include one or more sealing members140 that can extend around an inner surface 141 or outer surface 142 (asshown) of the retainer 110 and/or around an interior surface 126 (shownin FIG. 10D) or exterior surface 127 (shown in FIG. 10A) of the valvesupport 120 to prevent paravalvular (e.g., paraprosthetic) leaks betweenthe device 100 and the native tissue and/or between the retainer 110 andthe valve support 120.

The prosthetic heart valve device 100 can be movable between a deliveryconfiguration (not shown), an expanded configuration 102 (FIG. 10A), anda deployed configuration 104 (FIG. 10B). In the delivery configuration,the prosthetic heart valve device 100 has a low profile suitable fordelivery through small-diameter guide catheters positioned in the heartvia the trans-septal, retrograde, or trans-apical approaches describedherein. In some embodiments, the delivery configuration of theprosthetic heart valve device 100 will preferably have an outer diameterno larger than about 8-10 mm for trans-septal approaches, about 8-10 mmfor retrograde approaches, or about 8-12 mm for trans-apical approachesto the mitral valve MV. As used herein, “expanded configuration” refersto the configuration of the device when allowed to freely expand to anunrestrained size without the presence of constraining or distortingforces. “Deployed configuration,” as used herein, refers to the deviceonce expanded at the native valve site and subject to the constrainingand distorting forces exerted by the native anatomy.

Referring back to FIG. 3, “subannular,” as used herein, refers to aportion of the mitral valve MV that lies on or downstream DN of theplane PO of the native orifice. As used herein, the plane PO of thenative valve orifice is a plane generally perpendicular to the directionof blood flow through the valve and which contains either or both themajor axis MVA1 or the minor axis MVA2 (FIG. 5C). Thus, a subannularsurface of the mitral valve MV is a tissue surface lying on theventricular side of the plane PO, and preferably one that facesgenerally downstream, toward the left ventricle LV. The subannularsurface may be disposed on the annulus AN itself or the ventricular wallbehind the native leaflets LF, or it may comprise a surface of thenative leaflets LF, either inward-facing IF or outward-facing OF, whichlies below the plane PO. The subannular surface or subannular tissue maythus comprise the annulus AN itself, the native leaflets LF,leaflet/annulus connective tissue, the ventricular wall or combinationsthereof.

In operation, the prosthetic heart valve device 100 can beintravascularly delivered to a desired location in the heart, such as anintracardiac location near the mitral valve MV, while in the delivery(e.g., collapsed) configuration within a delivery catheter (not shown).Referring to FIG. 10B, the device 100 can be advanced to a positionwithin or downstream of the native annulus AN where the device 100 canbe released from the delivery catheter to enlarge toward the expandedconfiguration 102 (FIG. 10A). The device 100 will engage the nativetissue at the desired location, which will deform or otherwise alter theshape of the device 100 into the deployed configuration 104 (FIG. 10B).Once released from the catheter, the device 100 can be positioned suchthat at least a portion of the expandable retainer 110 engages asubannular surface of the native valve so as to resist systolic forcesand prevent upstream migration of the device 100 (FIG. 10B). In theembodiment illustrated in FIG. 10B, an upstream perimeter 113 of theretainer 110 engages the inward-facing surfaces IF (FIG. 3) of thenative leaflets LF, which are pushed outwardly and folded under thenative annulus AN. The leaflets LF engage a ventricular side of theannulus AN and are prevented from being pushed further in the upstreamdirection, thus maintaining the retainer 110 below the plane of thenative valve annulus. In some embodiments, however, some portions of theretainer 110 may extend above the annulus AN, with at least someportions of the retainer 110 engaging tissue in a sub annular locationto prevent migration of the device 100 toward the left atrium LA. Asshown in FIG. 10B, the leaflets LF can lie in apposition against theouter surface 142 of the retainer 110 forming a blood-tight seal withthe sealing member 140.

In accordance with aspects of the present technology, the expandableretainer 110, while in a deployed configuration 104, conforms to theirregularly-shaped mitral annulus AN, effectively sealing the device 100against the native annulus AN to anchor the device and to preventparavalvular leaks. As described further herein, the retainer 110mechanically isolates the valve support 120 from distorting forcespresent in the heart such that the retainer 110 may adapt and/or conformto native forces while the valve support 120 maintains its structuralintegrity. Accordingly, the retainer 110 can be sufficiently flexibleand resilient and/or coupled to the valve support 120 in such a manneras to mechanically isolate the valve support 120 from the forces exertedupon the retainer 110 by the native anatomy. Alternatively, or inaddition to the above features, the valve support 120 may be more rigidand/or have greater radial strength than the radial strength of theretainer 110 so as to maintain its cylindrical or other desired shapeand to ensure proper opening and closing of the prosthetic valve 130housed within the valve support structure 120. In some embodiments, thevalve support 120 has a radial strength of at least 100%, or in otherembodiments at least 200%, and in further embodiments at least 300%,greater than a radial strength of the retainer 110. In one embodiment,the valve support 120 can have a radial strength of approximately 10 Nto about 12 N. Thus, if deformed from its unbiased shape by exerting aradially compressive force against its circumference, the valve support120 can exhibit a hoop force which is about 2 to about 20 times greaterfor a given degree of deformation than will be exhibited by the retainer110.

The retainer 110 comprises a flexible, upstream portion of the device100 and is implanted such that at least a portion of the retainer 110engages tissue at or near the native mitral annulus. The retainer 110can be a generally outward oriented portion of the device 100, as shownin FIG. 10C. In one embodiment, the retainer 110 forms a donut-shapedflange 190 having an arcuate outer surface 142 for engaging tissue andan inner lumen defining a passage for blood to flow through the valvesupport 120. In another example, the outer surface 142 can have othershapes, such as linear, triangular, an irregular shape, etc. In someembodiments, the retainer 110 can include a plurality ofcircumferentially positioned, resiliently deformable and flexible ribs114 which are coupled at their downstream ends 116 to the valve support120. Once deployed, at least a portion of the upstream region 118 of theflexible ribs 114 can expand outward from the valve support 120 toengage a surface at or near the native valve (e.g., mitral valve).

Additionally, FIGS. 10A-10D also illustrate that the flexible ribs 114,in one embodiment, can have a general C-shape configuration with tips117 of the flexible ribs 114 and opening 119 of the C-shapeconfiguration oriented toward a longitudinal axis 101 of the device 100.As shown in FIGS. 10A-10D, the each individual flexible rib 114 can beindependent or otherwise unconnected to any other (e.g., adjacent)flexible rib 114 of the retainer 110. However, in some embodiments, notshown, the retainer 110 can have circumferential connectors connectingone or more flexible ribs 114 of the retainer 110. In some embodiments,the flexible ribs 114 may be divided along their length into multiple,separated segments (shown below with respect to FIGS. 13A-13G). Theplurality of flexible ribs 114 can be formed from a deformable materialor from a resilient or shape memory material (e.g., nitinol). In otherembodiments, the retainer 110 can comprise a mesh or woven constructionin addition to or in place of the flexible ribs 114. For example, theretainer 110 could include a plurality of flexible wires or filamentsarranged in a diamond pattern or other configuration. In a particularexample, the retainer 110 can be formed of a pre-shaped nitinol tubehaving, for example, a wall thickness of approximately 0.010 inches toabout 0.130 inches.

FIG. 11 shows an embodiment of the valve support 120 that can be used inthe various embodiments of the prosthetic heart valve device 100 shownin FIGS. 10A-10D. FIG. 11 is an isometric view of the valve support 120shown in an expanded configuration 102 in accordance with the presenttechnology. Referring to FIGS. 10A-10D and 11 together, severalembodiments of the valve support 120 can be generally cylindrical havingan upstream end 121 and a downstream end 123 formed around thelongitudinal axis 101 with a circular, oval, elliptical, kidney-shaped,D-shaped, or other suitable cross-sectional shape configured to supporta tricuspid or other prosthetic valve 130. In some embodiments, thevalve support 120 includes a plurality of posts 122 connectedcircumferentially by a plurality of struts 124. The posts 122 and struts124 can be arranged in a variety of geometrical patterns that can expandand provide sufficient resilience and column strength for maintainingthe integrity of the prosthetic valve 130. For example, the plurality ofposts 122 can extend longitudinally across multiple rows of struts 124to provide column strength to the valve support 120. However, in otherembodiments, the valve support 120 can include a metallic, polymeric, orfabric mesh or woven construction.

Generally, the plurality of posts 122 can extend along an axialdirection generally parallel to the longitudinal axis 101 and the struts124 can extend circumferentially around and transverse to thelongitudinal axis 101. The posts 122 can extend an entire longitudinalheight H₁ (shown in FIG. 10C) of the valve support 120 and in oneembodiment the height H₁ can be approximately 14 mm to about 17 mm.Referring to FIG. 11, the struts 124 can form a series of rings aroundthe longitudinal axis 101, wherein each ring has a circumferentiallyexpandable geometry. In the example shown in FIG. 11, the struts 124 areformed in a series of zig-zags to form a chevron configuration.Alternative expandable geometries can include sinusoidal patterns,diamond configurations, closed cells, open cells, or other expandableconfigurations. The plurality of struts 124 can attach to the pluralityof posts 122 so as to define a plurality of nodes 125 where the strutsand posts intersect. The plurality of struts 124 and the plurality ofposts 122 can be formed from a deformable material or from a resilientor shape memory material (e.g., nitinol).

As shown in FIG. 11, the valve support 120 has the interior surface 126and the exterior surface 127, and the valve support 120 is configured toreceive the prosthetic valve 130 within an interior lumen of the valvesupport 120 to inhibit retrograde blood flow (e.g., blood flow from theleft ventricle into the left atrium). Accordingly, the valve support 120can provide a scaffold to which prosthetic valve tissue can be securedand provide a scaffold that has sufficient axial rigidity to maintain alongitudinal position of the prosthetic valve 130 relative to theretainer 110. The valve support 120 can further provide such a scaffoldhaving radial rigidity to maintain circularity (or other desiredcross-sectional shape) to ensure that leaflets 132 of the prostheticvalve 130 coapt or otherwise seal when the device 100 is subject toexternal radial pressure. In one embodiment, the valve support 120 canhave a support region 145 along the longitudinal axis 101 that isconfigured to attach to the prosthetic valve, or in other embodiments,be aligned with the coaptation portion of the leaflets 132 (shown inFIG. 11).

The valve 130 may comprise a temporary or permanent valve adapted toblock blood flow in the upstream direction and allow blood flow in thedownstream direction through the valve support 120. The valve 130 mayalso be a replacement valve configured to be disposed in the valvesupport 120 after the device 100 is implanted at the native mitralvalve. The leaflets 132 may be formed of various flexible andimpermeable materials including PTFE, Dacron®, pyrolytic carbon, orother biocompatible materials or biologic tissue such as pericardialtissue or xenograft valve tissue such as porcine heart tissue or bovinepericardium. Other aspects of valve 130 are described further below.

The interior surface 126 within the lumen of the valve support 120 canbe covered at least partially by an impermeable sealing member 140 toprevent blood flow from inside the valve support 120 to the outside ofthe valve support 120, where it could leak around the exterior of thevalve support 120. In another embodiment, the sealing member 140 may beaffixed to the exterior surface 127 of the valve support 120 and, ineither embodiment, may be integrally formed with or attached directly tovalve 130. In an additional embodiment, the sealing member 140 can beapplied on at least portions of both the interior surface 126 and theexterior surface 127 of the valve support 120.

In accordance with aspects of the present technology and as shown inFIG. 11, the prosthetic valve 130 can be sutured, riveted, glued,bonded, or otherwise fastened to posts 122 or commissural attachmentstructures 128, which are configured to align with valve commissures C.The posts 122 or commissural attachment structures 128 can includeeyelets 129, loops, or other features formed thereon to facilitateattachment of sutures or other fastening means to facilitate attachmentof the prosthetic valve 130. In one embodiment, as shown in FIG. 11, theattachment structures 128 can be integrated into the structural frame ofthe valve support 120 such that the attachment structures 128 aredistributed around the circumference of the valve support 120 andfunction as posts 122. In other embodiments, not shown, the attachmentstructures 128 can be attachment pads formed on parts of the posts 122(e.g., along an upper end of the posts 122) or can be separatestructures that can be coupled to posts 122, struts 124 or othercomponents along the interior surface 126 of the valve support 120. Theprosthetic valve 130 may also be attached to the sealing member 140,which can be a sleeve attached to the interior surface 126 of the valvesupport 120.

Once attached, the prosthetic valve 130 can be suitable to collapse orcompress with the device 100 for loading into a delivery catheter (notshown). In one embodiment, the prosthetic valve 130 has a tri-leafletconfiguration, although various alternative valve configurations may beused, such as a bi-leaflet configuration. The design of the prostheticvalve 130, such as the selection of tri-leaflet vs. bi-leafletconfigurations, can be used to determine the suitable shape of the valvesupport 120. For example, for a tri-leaflet valve, the valve support 120can have a circular cross-section, while for a bi-leaflet valve,alternative cross-sectional shapes are possible such as oval or D-shapedcross-sections. In particular examples, the valve support can have acircular cross-sectional diameter of approximately 25 mm to about 30 mm,such as 27 mm.

In some arrangements, the valve support 120 can have a permanentprosthetic valve pre-mounted therein, or the valve support 120 may beconfigured to receive a separate catheter-delivered valve followingimplantation of the device 100 at the native mitral valve. Inarrangements where a permanent or replacement valve is desirable, thevalve support 120 can further include a temporary valve pre-mountedwithin the interior lumen. If a period of time between placement of thedevice 100 and further implantation of the permanent prosthetic valve isdesirable, a temporary valve sewn into or otherwise secured within thevalve support 120 can assure regulation of blood flow in the interim.For example, temporary valves may be used for a period of about 15minutes to several hours or up to a several days. Permanent orreplacement prosthetic valves may be implanted within a temporary valveor may be implanted after the temporary valve has been removed. Examplesof pre-assembled, percutaneous prosthetic valves include, e.g., theCoreValve ReValving® System from Medtronic/Corevalve Inc. (Irvine,Calif., USA), or the EdwardsSapien® valve from Edwards Lifesciences(Irvine, Calif., USA). If adapted to receive a separatecatheter-delivered valve, the valve support 120 may have features withinits interior lumen or on its upper or lower ends to engage and retainthe catheter-delivered valve therein, such as inwardly extending ridges,bumps, prongs, or flaps. Additional details and embodiments regardingthe structure, delivery and attachment of prosthetic valves, temporaryvalves and replacement valves suitable for use with the prosthetic heartvalve devices disclosed herein can be found in International PCT PatentApplication No. PCT/US2012/043636, entitled “PROSTHETIC HEART VALVEDEVICES AND ASSOCIATED SYSTEMS AND METHODS,” filed Jun. 21, 2012, theentire contents of which are incorporated herein by reference.

In some embodiments, a downstream portion 111 of the retainer 110 can becoupled to or near the upstream end 121 of the valve support 120 andextend outward and in an upstream direction from the valve support 120in a manner that does not unduly influence the shape of the valvesupport 120. Accordingly, in some embodiments, the retainer 110 can beconfigured to engage and deform to the shape of the native tissue on orunder the annulus while a cross-sectional shape of the valve support 120remains sufficiently stable or substantially undeformed. For example,the valve support 120 (e.g., at least at the upstream end 121) can bespaced longitudinally downstream from at least a tissue engaging portion112 of the retainer 110 such that if the retainer 110 is deformedinwardly, the cross-sectional shape of the valve support 120, whichremains positioned downstream of the tissue engaging portion 112 of theretainer 110, remains substantially undeformed. As used herein,“substantially undeformed” can refer to situations in which the valvesupport 120 is not engaged or deformed, or can refer to scenarios inwhich the valve support 120 can deform slightly but the prosthetic valve130 remains intact and competent (e.g., the leaflets 132 coaptsufficiently to prevent retrograde blood flow). In such arrangements,leaflets 132 of the prosthetic valve 130 can close sufficiently evenwhen the device 100 is under systolic pressures or forces from thepumping action of the heart.

As illustrated in FIGS. 10A-10D, the retainer 110 can be coupled to ornear the upstream end 121 of the valve support 110 the valve support 120in such that the valve support 120 and valve 130 reside within the leftventricle. Alternatively, the retainer 110 can be coupled to the valvesupport 120 anywhere along a length of the valve support 120 such thatthe valve support 120 and valve 130 can reside within the annulus orabove the annulus of the native heart valve. The valve support 120 andretainer 110 may be coupled by a variety of methods known in the art,e.g., suturing, soldering, welding, bonding, staples, rivets or otherfasteners, mechanical interlocking, friction, interference fit, or anycombination thereof.

FIGS. 12A-12H are side views of additional mechanisms of coupling thevalve support 120 to the retainer 110 that can allow mechanicalisolation of the valve support 120 from the retainer 110 in accordancewith additional embodiments of the present technology. Referring toFIGS. 12A-12D, the flexible ribs 114 can include rib posts 88 (FIG. 12A)that can be coupled to valve support posts 122 (FIG. 12C) usingindividual hypotubes 108 (shown in FIG. 12B). For example, as shown inFIG. 12D, the rib post 88 may be aligned with the individual valvesupport posts 122 and the hypotube 112 may be slipped over both thevalve support posts 122 and the rib posts 88. The hypotubes 108 can becrimped or otherwise adhered to valve support posts 122 and the ribposts 88 such that the flexible ribs 114 are connected to and alignedwith valve support posts 122 in a manner that allows the tissue engagingportions 112 to extend outward and in an upstream direction from thevalve support 120.

If the retainer 110 and the valve support are separate structures, asealing member 140 or other overlaying structure may be attached to boththe retainer 110 and the valve support 120 to interconnect the twostructures. For example, the valve support 120 can be covered by asealing member 140, such as a sleeve 146 that includes a plurality oflongitudinal pockets 109 formed (e.g., by suturing or bonding two layersof sleeve fabric together) or otherwise incorporated circumferentiallyaround the sleeve 146. As shown in FIG. 12E, each individual rib 114 canbe constrained within the pockets 109 formed in the sleeve 146, and thesleeve can be coupled to an interior or exterior surface 126, 127 of thevalve support (FIG. 11). In other embodiments, the valve support 120 andthe retainer 110 can be integrally formed with one another. For example,the flexible ribs 114 can be formed integrally with the posts 122 of thevalve support 120 (shown in FIGS. 10C and 12F.

In a further embodiment shown in FIGS. 12G-12H, the retainer 110 mayinclude a retainer frame 165, separate from the frame of the valvesupport 120 (FIG. 12G). The retainer frame 165, in one embodiment, mayinclude rib posts 88 connected circumferentially by deformable and/orflexible connectors 166, and can be configured to receive or partiallysurround the valve support 120 (FIG. 12H). In one arrangement, theretainer frame 165 can be delivered by catheter and deployed at a targetsite in the native heart valve and the valve support 120 can bedelivered separately following deployment and implantation of theretainer frame 165. In another arrangement, the retainer frame 165 canbe configured to receive or be coupled to the support frame 120 prior todelivery of the device 100 to the target site.

Referring back to FIGS. 10A-10D, the flexible ribs 114 can be less rigidthan the posts 122 and/or struts 124 of the valve support 120, allowinggreater flexibility in the retainer 110 and/or more stability to theshape and position of the valve support 120. In some embodiments, theflexibility of the retainer 110 can allow the retainer 110 to absorbdistorting forces as well as allow the device 100 to conform to theirregular, non-circular shape of the native annulus (while leaving thevalve support 120 substantially unaffected), encouraging tissue ingrowthand creating a seal to prevent leaks between the device 100 and thenative tissue. In addition, the flexible ribs 114 can be configured topress radially outward against the native valve, ventricular and/oraortic structures so as to anchor the device 100 in a desired position,as well as maintain an upstream deployed circumference 150′ larger thanthat of the native annulus such that subannular positioning effectivelyprevents upstream migration of the device 100 (described further belowin FIG. 18C). Furthermore, the flexible ribs 114 can have sufficientresilience and column strength (e.g., axial stiffness) to preventlongitudinal collapse of the retainer 110 and/or the device 100 and toresist movement of the device 100 in an upstream direction.

In accordance with embodiments of the present technology, the valve 130and valve support 120 are effectively mechanically isolated from thedistorting forces exerted on the retainer 110 by the native tissue,e.g., radially compressive forces exerted by the native annulus and/orleaflets, longitudinal diastolic and systolic forces, hoop stress, etc.For example, deformation of the retainer 110 by the native tissue canchange a cross-section of the retainer 110 (e.g., to a non-circular ornon-symmetrical cross-section), while the valve support 120 may besubstantially undeformed. In one embodiment, at least a portion of thevalve support 120 can be deformed by the radially compressive forces,for example, where the retainer 110 is coupled to the valve support 120(e.g., the downstream end 123). However, the upstream end 121 of thevalve support 120 and/or the valve support region 145 (FIG. 11) ismechanically isolated from the retainer 110 and the compressive forcessuch that at least the valve support region 145 can be substantiallyundeformed. Thus the valve support 120, and at least the valve supportregion 145, can maintain a circular or other desirable cross-section sothat the valve remains stable and/or competent. The flexibility of theribs 114 can contribute to the absorption of the distorting forces, andalso aid in mechanically isolating the valve support 120 and valve 130from the retainer 110 and from the native anatomy.

As shown in FIG. 10C, the retainer 110 is comprised of a series ofcircumferentially positioned flexible ribs 114 which are coupled orotherwise integrated at their downstream ends 116 to the valve support120. Unlike valve support posts 122, the flexible ribs 114 may not becircumferentially connected by struts which can allow for greatermovement, flexing, bending, rotating and/or deformation of theindividual ribs 114 and the retainer 110 as a whole. In certainembodiments in which the retainer 110 did include circumferential strutsor supports (not shown) for retaining or connecting the ribs 114, thestruts may be more flexible than the struts 124 utilized in the valvesupport 120.

FIGS. 13A-13G are partial side views of a variety of flexible ribconfigurations in accordance with additional embodiments of the presenttechnology. Referring to FIG. 13A, the ribs 114, in one embodiment, cangenerally have an arcuate or C-shaped tissue engaging portion 112 andinclude the rib post 88 at the downstream end 116 of the rib 114. Insome embodiments, the rib post 88 can be generally linear and have asuitable length L_(R1) for extending the retainer 110 a desirabledistance upstream from a connection (not shown) to the valve support120. In some embodiments, the rib post 88 can be generally parallel tothe longitudinal axis 101 of the device 100 and/or valve support 120(shown in FIG. 10C). Following the general curvature of the C-shapedtissue engaging portion 112 shown in FIG. 13A, a first segment 80 of thetissue engaging portion 112 can extend radially outward from the ribpost 88 beginning at a first transition 82. The first transition 82 canbe a curved or U-shaped section as shown to orient the first segment 82outward from the rib post 88. The first segment 80 can be arcuate orgenerally curved in an outward and upstream direction to reach a secondtransition 84. A second segment 86 of the tissue engaging portion 112can be arcuate or generally curved and extend (e.g., relative to the ribpost 88) from the second transition 84 in an upstream and inwarddirection. The second segment 86 can also curve slightly downstream atthe rib tip 117. The opening 119 of the C-shaped tissue engaging portion112 of the rib 114 is created in the space between the first transition82 and the rib tip 117.

Additional embodiments of rib shapes are shown in FIGS. 13B-13G. Forexample, rib segments, such as the first and second segments 80, 86, canbe generally linear (FIGS. 13B-13E). Other embodiments of tissueengaging portion 112 can have transitions 82 and 84 with less curvatureor greater curvature. For example, the first transition segment 82 maycomprise a curved section with a distinct inflection point (shown inFIGS. 13A and 13C-13E) or a short continuous segment with a constantradial curve (FIG. 12B). The tissue engaging portion 112 can alsoinclude additional transitions and/or segments to form desirable ribshapes, such as generally square-shaped (FIG. 13B), or generallytriangular-shaped (FIGS. 13C-13E) tissue engaging portions 112. Similarto the embodiment of the tissue engaging portion 112 shown in FIG. 13A,the tissue engaging portion 112 shown in FIGS. 13B-13E have the openings119 which can face inward toward a retainer interior (shown in FIGS.10A-10D); however, one of ordinary skill in the art will recognize thatthe ribs 114 can be oriented in a different direction, such as havingthe opening 119 facing outward with respect the longitudinal axis 101 ofthe device 100 (not shown). Additional embodiments of the tissueengaging portion 112 can be formed without openings 119.

In other embodiments, the tissue engaging portion 112 may take on otherunique geometries. As shown in FIG. 12F, the tissue engaging portion 112may coil or extend around an axis 90 transverse to the longitudinal axis101. Or, as shown in FIG. 12G, the tissue engaging portion 112 may havemultiple segments extending radially outward and/or multiple segmentsextending radially inward with respect to the rib post 88 in anirregular or in a patterned configuration.

Referring back to FIG. 13A, the tissue engaging portion 112 can have aheight H₁ between an upper surface 74 and a lower surface 76.Accordingly, in addition to the shape of the tissue engaging portion112, the overall height H₁ of the tissue engaging portion 112 can beselected to accommodate the anatomy at the desired target location ofthe heart valve.

Referring again to FIG. 13A, the tissue engaging portion 112 of the rib114 can be configured to absorb, translate and/or mitigate distortingforces present with the heart during, for example, systole and diastole.The shape of the tissue engaging portion 112 can be selected toaccommodate forces, such as radially compressive forces, e.g., exertedby the native annulus and/or leaflets Fa, longitudinal diastolic Fd andsystolic Fs forces, hoop stress, etc. Absorption of the distortingforces can serve to mechanically isolate the retainer 110 from the valvesupport 120. In accordance with the present technology, the ribs 114 mayflex, bend, rotate or twist under the distorting forces while the valvesupport 120 substantially maintains its rigidity and/or original shape(e.g., a generally circular shape). In a particular example, the device100 can include a tricuspid valve 130 retained within a generallycircular valve support 120 (FIGS. 10A-11). When deployed andoperational, the cross-sectional shape of the valve support 120 canremain sufficiently stable when the retainer 110 is deformed in anon-circular shape by engagement with the tissue such that the valve 130remains competent.

FIGS. 14A-14J are side views of various flexible ribs 114 flexing inresponse to a distorting force F in accordance with further embodimentsof the present technology. The degree of flexibility of individual ribs114 (and thus the retainer 110) may be consistent among all ribs 114 ofa retainer 110, or, alternatively, some ribs 114 may be more flexiblethan other ribs 114 within the same retainer 110. Likewise, a degree offlexibility of individual ribs 114 may be consistent throughout anentire length of the rib 114 or curvature of the tissue engaging portion112, or the degree of flexibility can vary along the length and/orcurvature of each rib 114.

As shown FIGS. 14A-14J, the tissue engaging portions 112 of the ribs 114may flex relative to the rib post 88 in response to varying distortingforces F that can be applied by the surrounding tissue during or afterimplantation of the device 100. From a static position (FIG. 14A), thetissue engaging portion 112 a may flex downward to a position 112 b(FIG. 14B) or upward to a position 112 c (FIG. 14C) in response to adownward force F₁ or an upward force F₂, respectively. Similarly, thetissue engaging portion 112 a may flex inward to a position 112 d (FIG.14D) or outward to a position 112 e (FIG. 14E) in response to alaterally directed inward force F₃ or a laterally directed outward forceF₄, respectively. As shown in FIGS. 14A-14E, the tissue engaging portion112 a may flex and/or rotate inwardly/outwardly in response to thelaterally directed forces F₃, F₄, or upward/downward in response to thegenerally vertically directed forces F₁, F₂ without altering the generalshape of the tissue engaging portion 112. In one embodiment, theposition of the tissue engaging portion 112 can occur by flex orrotation around the first transition 82 (FIGS. 14A-14E).

In other arrangements, the rib 114 can be configured to alter the shapeof the tissue engaging portion 112 a in response to forces, such as tothe shape/position 112 f in response to the downward force F₁ (FIG. 14F)and to the shape/position 112 g in response to the upward force F₂ (FIG.14G). Alteration of the shape and/or position of the tissue engagingportion 112, as shown in FIGS. 14F-14G, may occur by flexing, rotatingand/or deformation around segments 80, 86 and/or transitions 82, 84, forexample. As shown in FIGS. 14H-14J, the tissue engaging portion 112 a(FIG. 14H) may also flex and/or rotate laterally (e.g., to positions 112i or 112 j) in response to a laterally-directed force F₅, by bending attransition 82, for example, at unique and variable splay angles A_(s)off a midline 89 such that the rib tips 117 may be splayed away fromeach other.

In addition to having a variety of shapes and variations in flexibility,individual ribs 114 can also be placed in a variety of positions arounda circumference 150 of the retainer 110. FIGS. 15A-15E are schematic topviews of the prosthetic heart valve device 100 showing a variety of ribconfigurations in accordance with further embodiments of the presenttechnology. FIG. 15A shows and embodiment of the device 100 having aplurality of ribs 114 symmetrically and evenly spaced around thecircumference 150 of the retainer 110. In some embodiments, the device100 can include a first plurality of ribs 114 a and second plurality ofribs 114 b (FIG. 15B). In some embodiments, the first plurality of ribs114 a can have a characteristic different than the second plurality ofribs 114 b. Various characteristics could include size of the rib, ribshape, rib stiffness and the number of ribs 114 within a given area ofthe retainer 110. As shown in FIGS. 15C and 15D, the retainer 110 caninclude multiple groups of ribs 114 spaced symmetrically (FIG. 15C) orasymmetrically (FIG. 15D) around the circumference 150 of the retainer110. Referring to FIG. 15C, the groups of ribs 114 c and 114 e mayinclude different numbers of ribs 114 than in other groups (e.g., 114d). In other embodiments, the ribs 114 can be unevenly spaced around thecircumference 150 of the retainer 110 (FIG. 15E). The retainer 110 caninclude, in one embodiment, between approximately 2 ribs to about 30ribs, and in another embodiment, between approximately 6 ribs to about20 ribs.

FIGS. 16A-16B are schematic side and cross-sectional views of theprosthetic heart valve device 100 showing additional embodiments of theretainer 110 in accordance with the present technology. In someembodiments, the retainer 110 can be formed from a self-expanding mesh180 or weave of material formed from a deformable material or aresilient or shape memory material (e.g., nitinol) that can evert (FIG.16A) or that can roll (FIG. 16B) to form the retainer 110. In otherembodiments, the retainer 110 can comprise the self-expanding mesh orwoven construction in addition to the flexible ribs 114. In oneembodiment, the self-expanding mesh 180 could include a plurality offlexible wires or filaments arranged in a diamond pattern (FIG. 16A) orother configuration. In a particular example, the retainer 110 can beformed of a pre-shaped nitinol tube having, for example, a wallthickness of approximately 0.010 inches to about 0.130 inches.

The flexible characteristics of the individual ribs 114 can allow forthe flexibility and conformability of the retainer 110 to engage andseal the device 100 against uneven and uniquely-shaped native tissue.Additionally, the flexibility can assist in creating a seal between thedevice 100 and the surrounding anatomy. FIG. 17A is a schematic top viewof a native mitral valve MV illustrating the minor axis 50 and majoraxis 55, and FIGS. 17B-17C are schematic top views of an retainer 110 inan expanded configuration 102 and in a deployed configuration 104,respectively, overlaying the schematic of the native mitral valve MV inaccordance with an embodiment of the present technology.

Referring to FIG. 17B, the retainer 110 can have an outer circumference150 with a diameter D₁ that is greater than the minor axis 50 (FIG. 17A)of the native annulus, and usually less than the major axis 55 of theannulus, when the retainer 110 is in an expanded configuration 102(shown as dashed lines). In other embodiments, the retainer 110 may havea diameter D₁ at least as large as the distance between the nativecommissures C, and may be as large as or even larger than the major axis55 of the native annulus. In some embodiments, the outer circumference150 of the retainer 110 has the diameter D₁ which is approximately 1.2to 1.5 times the diameter (not shown) of the valve support 120 (or theprosthetic valve 130), and can be as large as 2.5 times the diameter ofthe valve support 120 (or the prosthetic valve 130). While conventionalvalves must be manufactured in multiple sizes to treat diseased valvesof various sizes, the valve support 120 and the prosthetic valve 130, inaccordance with aspects of the present technology, may be manufacturedin just a single diameter to fit a multitude of native valve sizes. Forexample, the valve support 120 and the prosthetic valve 130 do not needto engage and fit the native anatomy precisely. In a specific example,the valve support 120 may have a diameter (not shown) in the range ofabout 25 mm to about 32 mm for adult human patients. Also in accordancewith aspects of the present technology, the retainer 110 may be providedin multiple diameters or having a variable size circumference 150 to fitvarious native valve sizes, and may range in diameter from about 28 mmto about 80 mm, or in other embodiments, greater than 80 mm.

The top view of the retainer 110 shown in FIG. 17C illustrates howflexibility and/or deformation of one or more flexible ribs 114 and/orrib segments allows the retainer 110 to distort relative to the expandedconfiguration 102, as shown by the dashed lines, into a deployedconfiguration 104, as shown by the bolded lines. As shown in FIG. 17C,the retainer 110, when deployed or implanted at or under the mitralvalve annulus, can conform to the highly variable native mitral valvetissue shape MV, as shown in the dotted lines. The ribs 114 can bend,twist, and stretch such that the overall shape of the retainer 110 has adeployed (e.g., a generally more oval or D-shaped, or other irregularshape) configuration 104 instead of a fully expanded configuration 102.Referring to FIGS. 17B-17C together, the retainer 110 covers the mitralvalve commissures C in the deployed configuration 104, whereas thecommissures C would be left unsealed or exposed in the more circularexpanded configuration 102, potentially allowing paravalvular leaks. Theretainer 110 could also be pre-shaped to be in a generally oval orD-shape, or other shape, when in an unbiased condition.

In many embodiments, the retainer 110 can have sufficient flexibilitysuch that the retainer 110 conforms to the native mitral annulus when inthe deployed configuration 104 (FIG. 17C), however, the retainer 110 canbe configured to remain biased towards its expanded configuration 102(e.g., FIGS. 10A and 17B) such that, when in the deployed configuration104, the retainer 110 pushes radially outwards against the nativeannulus, leaflets, and/or ventricular walls just below the annulus. Insome arrangements, the radial force generated by the biased retainershape may be sufficient to deform the native anatomy such that the minoraxis 50 (FIG. 17A) of the native valve is increased slightly, and/or theshape of the annulus is otherwise altered. Such radial force can enhanceanchoring of the device 100 to resist movement toward the atrium whenthe valve 130 is closed during ventricular systole as well as movementtoward the ventricle when the valve 130 is open. Furthermore, theresulting compression fit between the retainer 110 and leaflets and/orventricular walls or other structures helps create a long-term bondbetween the tissue and the device 100 by encouraging tissue ingrowth andencapsulation.

FIG. 18 is a side view of a prosthetic heart valve device 100 shown inan expanded configuration 102 in accordance with a further embodiment ofthe present technology. The device 100 can include features generallysimilar to the features of the prosthetic heart valve device 100described above with reference FIGS. 10A-17C. For example, the device100 includes the valve support 120 and the prosthetic valve 130 housedwithin an interior lumen of the valve support 120. However, in theembodiment shown in FIG. 18, the device 100 includes a retainer 210having an oval or D-shaped upstream perimeter 213 and a plurality ofelevations around a circumference 250 of the retainer 210 such that theretainer 210 is suitable for engaging and conforming with tissue in thesubannular region of the mitral valve.

Similar to the retainer 110 of device 100 (FIG. 10A), the tissueengaging portion 212 of the retainer 210 can be a generally outwardoriented portion of the device 100. As shown in FIG. 18, the retainer110 can include of a series of circumferentially positioned, resilientlydeformable and flexible ribs 214. In other embodiments, the retainer 210can include flexible wires or filaments arranged in a diamond pattern orconfiguration (not shown). The flexible ribs 214 can, in someembodiments, provide column strength sufficient to inhibit movement ofthe device 100 relative the annulus under the force of systolic bloodpressure against the valve 130 mounted in the valve support 120.

In some embodiments, the upstream perimeter 213 of the retainer 210 doesnot lie in a single plane. For example, the ribs 214 can have variablelengths and/or be off-set from each other at variable angles such that adistance (e.g., elevation) between a downstream perimeter 215 and theupstream perimeter 213 can vary around the circumference 250. Forexample, the upstream perimeter 213 can form a rim having a plurality ofpeaks 251 and valleys 252 for adapting to the shape of the native mitralvalve (see FIG. 5C). As used herein, “peaks” and “valleys” refers toportions of the upstream perimeter 213 having an undulating shape formedby changes in elevation with respect to the downstream perimeter 215. Insome embodiments, the peak portions of the upstream perimeter 213 areabout 2 to about 20 mm, or more preferably about 5 mm to about 15 mm,higher (further upstream) than the valley portions relative to areference plane perpendicular to the direction of blood flow through thevalve.

In one embodiment, the upstream perimeter 213 of the retainer 210 canhave two peaks 251 that are separated by two valleys 252. In someembodiments, a first peak can have a different shape or elevation thanthat of a second peak. In other embodiments, the shape of a valley 252can be different than a shape of an inverted peak 251. Accordingly, thepeaks 251 and valleys 252 can be asymmetrically positioned and shapedaround the circumference 250 of the retainer 210. In variousarrangements, the valleys 252 can be configured for positioning alongcommissural regions of the native annulus, and the peaks 251 can beconfigured for positioning along leaflet regions of the native annulus.In one embodiment, the peaks 251 can have apices configured to bepositioned near midpoint regions of the leaflets.

Although the retainer 210 is deformable in response to distorting forcesexerted by the native anatomy, the valve support 120 can have sufficientrigidity to maintain a circular or other original cross-sectional shape,thus ensuring proper functioning of the prosthetic valve leaflets 132when opening and closing. Such mechanical isolation from the retainer210 may be achieved by the valve support 120 having sufficient rigidityto resist deformation while retainer 210 is deformed, and by selecting alocation and means for coupling the valve support 120 to the retainer210 so as to mitigate the transmission of forces through the retainer210 to the valve support 120 or the prosthetic valve 130 containedtherein. For example, the valve support 120 may be coupled to theretainer 210 only at the upstream end 121 of the valve support 120, andthe retainer 110 can further extend away from the valve support in anoutward and upstream direction. Thus, forces exerted on the retainer 210by the annulus or subannular tissue can be absorbed by the flexible ribs214 of the retainer 210 to mitigate transmission of such forces to thevalve support 120.

Additional Components and Features Suitable for Use with the ProstheticHeart Valve Devices

Additional components and features that are suitable for use with theprosthetic heart valve devices (e.g., devices 100 described above) aredescribed herein. It will be recognized by one of ordinary skill in theart that while certain components and features are described withrespect to a particular device (e.g., device 100), the components andfeatures can also be suitable for use with or incorporated with otherdevices as described further herein.

As discussed above with respect to FIG. 10A, some embodiments of theprosthetic heart valve device 100 can include a sealing member 140 thatextends around portions of the retainer 110 and/or the valve support120. For example, the embodiment illustrated in FIG. 10A has a sealingmember 140 around the outer surface 142 of the retainer 110 and aroundan exterior surface 127 of the valve support 120 to prevent paravalvularleaks both between the device 100 and the anatomy but also throughcomponents of the device 100. Additionally, the sealing member 140 canbe configured to promote in-growth of tissue for facilitatingimplantation of the device 100 in the native heart valve. In oneembodiment, the sealing member can be a sleeve 146 (FIG. 10A) which caninclude an impermeable sealing material that is cylindrical andconfigured to fit within or over various frame or skeleton structures ofthe device 100 as further described below.

In FIG. 10A, the sleeve 146 is on the exterior surface 127 of the valvesupport 120; however, in other embodiments, the sleeve 146 or othersealing member 140 can be disposed on the interior surface 126 of thevalve support 120. While FIG. 10A illustrates an embodiment of thedevice 100 in which the sleeve 146 is disposed on the outer surface 142of the retainer 110, one of ordinary skill will recognize otherconfigurations where the sleeve 146 can be disposed on the inner surface141 of the retainer 110.

One of ordinary skill in the art will recognize that the sealing members140, such as the sleeves 146, can fully cover the surfaces 126, 127, 141and 142 or in other embodiments, at least partially cover the surfaces126, 127, 141 and 142 of the retainer 110 and the valve support 120,respectively. Any combination of sealing members 140 is contemplated.Additionally, the sealing member 140 can comprise a single continuoussheet of fluid impervious material (e.g., for covering a surface 141,142 of the retainer 110 and a surface 126, 127 of the valve support120), which could create a seal between the retainer 110 and the valvesupport 120. In various embodiments, the sealing member 140, such as thesleeve 146, can comprise a fabric or other flexible and biocompatiblematerial such as Dacron®, ePTFE, bovine pericardium, or other suitableflexible material to integrate with tissue and minimize paravalvularleaks. In other embodiments, the sealing member 140 can include apolymer, thermoplastic polymer, polyester, Goretex®, a synthetic fiber,a natural fiber or polyethylene terephthalate (PET). The valve 130 mayalso be attached to the sealing member 140 or integrally formed with thesealing member 140.

The prosthetic heart valve device 100 can also include additionalsupport features for maintaining a desired shape and/or rigidity of thevalve support 120 or the retainer 110. FIG. 19 is an isometric view ofthe prosthetic heart valve device 100 having a connecting ring 156 inaccordance with an embodiment of the present technology. As shown inFIG. 19, the connecting ring 156 can be coupled to plurality ofcommissure posts 158 integrated and/or coupled to the valve support 120.As shown in FIG. 19, the connecting ring 156 can be coupled to thedownstream ends 157 of the commissure posts 158; however, the connectingring 156 may also be coupled to another portion of the commissure posts158 or the valve support 120. The connecting ring 156 can have a varietyof symmetrical or non-symmetrical geometrical cross-sections and canprovide support for the commissure posts 158 to keep the posts frombending or deforming.

FIGS. 20A-20B are isometric views of a retainer support ring 160 and theprosthetic heart valve device 100 having the retainer support ring 160in accordance with an additional embodiment of the present technology.As shown in FIG. 20A, the retainer support ring 160 can be acircular-shaped ring element that has a ring circumference 151approximately similar to a desired circumference 150 of the retainer 110when the device 100 is in the expanded configuration 102. In anotherembodiment, not shown, the support ring 160 can have a different shape(e.g., oval, D-shaped, irregular, etc.) such that the support ring 160can be configured to encourage the retainer 110 into the differentshape. In one embodiment, the support ring 160 can be formed from ashape memory material (e.g., nitinol) that can collapse in a deliveryconfiguration (not shown) to fit within a delivery catheter, and toexpand toward the ring circumference 151 when the device 100 is deployedat the target location at or near the native heart valve. In otherembodiments, the retainer support ring 160 may be a solid, coiled, orwoven wire or band of a flexible, resilient material (e.g.,biocompatible polymers or metals) with the desired degree of rigidity.

In FIG. 21B, the sealing member 140, such as the sleeve 146, is pulledaway for clarity only to expose the retainer support ring 160 disposedwithin the inner surface 141 of the retainer 110. For example, thesupport ring 160 can be configured to be disposed in the openings 117 ofthe C-shaped ribs 114 of the retainer 110 to provide additionalcircumferential support for the retainer 110, enhance radial rigidityand to resist and distribute distorting forces exerted on the retainer110 during and after delivery of the device 100.

Prosthetic Heart Valve Devices Having Stabilizing Members

FIG. 22 illustrates one embodiment of the prosthetic heart valve device100 in an expanded configuration 102 that further comprises one or morestabilizing members 501 to help stabilize the device 100 at the nativevalve site and, in some embodiments, prevent tilting or lateralmigration, or to inhibit upstream or downstream migration of the device100. In some embodiments, the stabilizing members 501 may comprise oneor more arms 510 extending from a lower or downstream end 123 of thevalve support 120, or from the commissure posts 158. In anotherembodiment, the arms 510 can be configured to extend from a downstreamend of rib posts 88 (shown in FIG. 22). The arms 510 are configured toengage the native tissue, e.g. the valve leaflets, subannular tissue, orventricular wall, either inside or outside the native leaflets,depending on the configuration.

FIG. 22 is an enlarged schematic, side view of a prosthetic heart valvedevice 100 having an extended arm in accordance with an embodiment ofthe present technology. As shown in FIG. 22, an individual arm 510 maycomprise an arm body 512, an arm extension 514, and an arm tip 516. Thearm body 512 has an arm body length L₁ and may connect to a post 511 ata first joint 508. The post 511 can be a valve support post 122, aretainer rib post 88, and/or another feature of the device 100 (e.g., acommissure post 158). In one embodiment, the arm body 512 may be welded,bonded, crimped, or otherwise mechanically attached to the post 511 thefirst joint 508. Alternatively, arms 510 may be integrally formed withposts 511, such as the valve support posts 122 or the rib posts 88. Afirst arm angle A_(A1) is formed by the intersection of the axes of post511 and the arm body 512 and is selected such that the arm 512 ispositionable so that the tip 516 can engage the native tissue at adesired location, e.g. the subannular tissue or ventricular wall behindthe native leaflets. FIGS. 23A-23C are enlarged partial side views of aprosthetic heart valve device 100 having arms 510 coupled to the deviceat various angles with respect to a longitudinal axis 101 of the device100 in accordance with further embodiments of the present technology. Inone embodiment, the first arm angle A_(A1) can be about 100° to about45°. In other embodiments, the first arm angle A_(A1) can be an obtuseangle (FIG. 23A), generally perpendicular or approximately a 90° angle(FIG. 23B), or an acute angle (FIG. 23C).

Referring back to FIG. 22, the arm body 512 can connect to the armextension 514 at a distal end of the arm body 512. The arm extension 514can have an arm extension length L₂ which can be selected or optimizedfor penetrating a desired distance into the native tissue, such as about0.5-2 mm. The arm extension 514 can extend from the arm body 212 atsecond arm angle A_(A2). The second arm angle A_(A2) can be formed bythe intersection between the arm extension 514 and arm body 512 and beselected to provide the desired angle of engagement with the nativetissue, such as about 100° to about 135°. In other embodiments, the armextension 514 may be parallel or collinear with the arm body 512 (notshown), or may be eliminated entirely. The arm extension 514 terminatesat the arm tip 516. In embodiments without an arm extension 514, the armtip 516 can be the most distal portion of the arm body 512 (not shown).

The arm 510 may have an arm height H_(A1) extending from the first joint508 to the most distal reaching point of the arm, which could be the armtip 516 (shown in FIG. 22) along an axis parallel to the longitudinalaxis 101 of the device 100. The arm height HAI can be selected oroptimized such that the arm tip 516 engages a desired location in thesubannular anatomy when the device 100 is in a desired longitudinalposition relative to the native mitral valve (e.g., when the retainer110 is in engagement with the subannular tissue). The arm height H_(A1)will depend upon of the overall height of the retainer 110 and/or valvesupport 120 as well as the location of the joint 508. FIGS. 24A-24C areenlarged, partial side views of prosthetic heart valve devices havingarms 510 of various lengths (L₁+L₂), and accordingly having variableheights H_(A1). As shown, the arm height H_(A1) may be greater than theoverall height H_(D1) of the device 100 (represented by the post 511 andrib 114) (FIG. 24A), be intermediate between the respective heightsH_(D1), H_(V1) of the retainer 110 (represented by the tissue engagingportion 112 of the rib 114) and the valve support 120 (represented bypost 511) (FIG. 24B), or be less than the overall height H_(D1) of boththe retainer 110 (represented by rib 114) and the valve support 120(FIG. 24C).

Additional details and embodiments regarding the structure andattachment of arms or other stabilizing members suitable for use withthe device 100 can be found in International PCT Patent Application No.PCT/US2012/043636, entitled “PROSTHETIC HEART VALVE DEVICES ANDASSOCIATED SYSTEMS AND METHODS,” filed Jun. 21, 2012, the entirecontents of which are incorporated herein by reference.

FIGS. 25A-25E are cross-sectional views of a heart with an implantedprosthetic heart valve device 100 having arms 510 a disposed on aninward-facing surface of the leaflets LF. The embodiments of prostheticheart valve devices 100 illustrated in FIGS. 25A-25E have arms 510 aconfigured to expand to a position radially inside the leaflets LF,radially outside the leaflets LF, or a combination of inside and outsidethe leaflets LF. For example, FIG. 25A shows the arms 510 a expandingand engaging an inward surface of the leaflets LF and shows the arms 510a partially piercing the leaflets LF. In another example illustrated inFIG. 25B, the arms 510 a may fully penetrate the leaflets LF. In afurther example, the device 100 can incorporate arms 510 a that 1)completely penetrate the leaflets LF and 2) partially pierce subannulartissue (FIG. 25C). Referring to FIG. 25D, the device 100 can beconfigured to incorporate arms 510 a that fully penetrate both theleaflets LF and the annular tissue of the mitral valve MV. In anadditional example, FIG. 25E shows the arms 510 a radially engaging agreater length of the leaflet LF along the arm 510 a as well asoptionally piercing the leaflet LF and/or annular tissue AN at the armtip 516. In some embodiments, all or a portion of the arms 510 a mayhave a curvature or other suitable shape which allows the leaflets LF toconform to the outer surface of the arms 510 a.

FIGS. 26A-26C are schematic views illustrating various embodiments oftissue engaging elements 170 for use with prosthetic heart valve devices100 in accordance with the present technology. Tissue engaging elements170 can include any feature that engages tissue in an atraumatic manner,such as a blunt element, or which partially pierces or fully penetratescardiac tissue, such as a barb or spike. As used herein, “tissueengaging” refers to an element 170 which exerts a force on the tissue Tbut does not necessarily pierce the tissue T, such as being atraumaticto the tissue T, as shown in FIG. 26A. As used herein, “partiallypiercing” refers to a tissue engaging feature 170 which at leastpartially penetrates the tissue T but does not break through an oppositesurface S, as shown in FIG. 26B. As used herein, “fully piercing” refersto a tissue engaging feature 170 which can both enter and exit thetissue T, as shown in FIG. 26C. “Piercing” alone may refer to eitherpartial or full piercing. Tissue engaging elements 170 may take the formof spikes, barbs, or any structure known in art capable of piercingcardiac tissue, or alternatively, any blunt or atraumatic featureconfigured to apply pressure on the cardiac tissue without piercing thetissue. Further details on positioning of such elements are describedherein.

FIGS. 27A-27C are enlarged, partial side views of a prosthetic heartvalve device 100 having arms 510 a with tissue engaging elements 170configured to engage an inward-facing surface of the leaflets inaccordance with various embodiments of the present technology. Asillustrated in FIGS. 27A-27C, tissue engaging elements 170 can beincorporated on and extend from the arms 510 a in either a downstreamdirection (FIG. 27A), upstream direction (FIG. 27B), or in both thedownstream and upstream directions (FIG. 27C). In other embodiments, thetissue engaging elements 170 can be incorporated on and extend from thecomponents of the retainer 110 and/or the valve support 120 in either orboth the upstream and downstream directions.

FIGS. 28A-28B are side views showing prosthetic heart valve devices 100implanted at a mitral valve MV (illustrated in cross-section) in adeployed configuration 104, wherein the devices have arms 510 b forengaging an outward-facing surface of the native leaflets LF inaccordance with various embodiments of the present technology. FIG. 28Ashows an embodiment of the device 100 that includes arms 510 bconfigured to reach behind the leaflets LF such that the leaflets LF areeffectively sandwiched between the arms 510 b and the outer surface 142of the retainer 110 and/or the exterior surface 127 of the valve support120. In another embodiment, and as shown in FIG. 28B, the arms 510 b maycause leaflets LF to fold upon themselves in the space between the arms510 b and the outer surface 142 of the retainer 110 and/or the exteriorsurface 127 of the valve support 120. FIG. 28C is an enlarged, partialside view of a prosthetic heart valve device 100 having the arm 510 bwith tissue engaging elements 170 configured to engage an outward-facingsurface of the leaflets in accordance with various embodiments of thepresent technology. As shown in FIG. 28C, the arm 510 b includes tissueengaging elements 170 on an inside surface 520 of the arm 510 b suchthat they are oriented toward the leaflet tissue.

In accordance with another embodiment of the present technology, FIG.29A is a side view showing a prosthetic heart valve device 100 implantedat a mitral valve MV (illustrated in cross-section). The device shown inFIG. 29A has arms 510 b for engaging an outward-facing surface of thenative leaflets LF and arms 510 a for engaging an inward-facing surfaceof the native leaflets LF. Inside/outside arms 510 a, 510 b may furthercomprise tissue engaging elements 170 on a radially inside surface orradially outside surface of the arms 510 a, 510 b, respectively, forengaging or piercing the leaflet tissue. The arrangement ofinside/outside arms 510 a, 510 b around a circumference of the device100 can alternate in a pre-designed pattern. For example, inside arms510 a can alternate with outside arms 510 b as shown in FIG. 29B, oralternatively, arms 510 a, 510 b may extend radially outward and/orradially inward randomly or at irregular intervals, depending onplacement of the device 100 and with respect to alignment with thenative posterior and anterior leaflets.

FIGS. 30A and 30C are isometric views of the prosthetic heart valvedevice 100 having arms 510 with a similar profile as a profile of theretainer 110, and FIGS. 30B and 30D are side views of the prostheticheart valve devices 100 of FIGS. 30A and 30C, respectively, and shownimplanted at a mitral valve (illustrated in cross-section) in accordancewith another embodiment of the present technology. As shown in FIG. 30A,the arms 510 can have a similar overall profile as a profile of theretainer 110. The retainer 110 can include ribs 114 having varyingshapes, sizes and/or outwardly or inwardly oriented tissue engagingportion segments 80, 86 for forming the overall retainer 110 profile.Accordingly, the arms 510 can also have varying shapes, sizes and/oroutwardly or inwardly oriented arm segments that mimic the retainer 110profile. In the embodiment shown in FIGS. 30A-30B, the arms 510 areconfigured to clamp leaflets LF and/or the annulus AN tissue between thearms 510 and the tissue engaging portion 112 of the ribs 114 so as toconform the leaflet tissue to the shape of the retainer 110 for enhancedsealing and anchoring of the device 100. For example, FIG. 30Aillustrates one embodiment in which the arm extensions 514 and/or thearm bodies 512 may partially mimic the shape of the ribs 114 and/or thetissue engaging portion segments 80, 86.

FIGS. 30C-30D illustrates another embodiment in which first and secondarm extensions 514 a and 514 b and/or arm bodies 512 more closely followthe shape of the ribs 114. For example, the arms 510 can include the armbody 512 and multiple arm extensions (e.g., first arm extension 514 aand second arm extension 514 b) that are configured to clamp leaflets LFand/or the annulus AN tissue between the arms 510 and the tissueengaging portion 112 of the ribs 114 so as to conform the leaflet tissueto both lower and upper regions of the tissue engaging portion 112 forenhanced sealing and anchoring of the device 100. Embodimentsencompassed by FIGS. 30A-30D can apply to outward surface engaging arms510 b and/or inward surface engaging arms 510 a.

In some embodiments, the prosthetic heart valve device 100 mayincorporate a plurality of arms 510 around a circumference of the device100; however, in other embodiments, the device 100 may include theplurality of arms in groupings (e.g., first and second groupings so asto engage the posterior and anterior leaflets, respectively).Additionally, the arms 510 may extend from the retainer 110 and/or valvesupport 120 independently of other components including other arms 510,such as shown in FIG. 31A. In other embodiments and as shown in FIG.31B, the device 100 may further include at least one first arm 510 xinterconnected with at least one second arm 510 y by interconnecting armstruts 522. The arm struts 522 can be configured to be circumferentiallyexpandable and may connect all arms 510 (e.g., arm 510 x and 510 y) orone or more groups of arms 510. In some embodiments, the arm struts 522can limit the outward extension of the arms 510 x, 510 y away from thedevice 100.

In accordance with aspects of the present technology, the arms 510 canbe coupled to and/or extend from components of the device 100symmetrically and/or asymmetrically around the circumference 150 of thedevice 100. FIGS. 32A-32D are schematic top views of arm locationpatterns with respect to the ribs 114 of the retainer 110 (e.g., asshown in FIG. 31A). The arms 510 can be interspersed with ribs 114(FIGS. 32A and 32C), in the same radial plane as the ribs 114 of theretainer 110 (FIG. 32B), or both interspersed and in plane with the ribs114 (FIG. 32D). Further, the arms 510 may be configured to extendoutside the expanded outer circumference 150 of the retainer 110 (FIG.32B), inside the expanded outer circumference 150 of the retainer 110(FIG. 32A), extend to the same outer circumference 150 of the retainer110 (FIG. 32C), or a combination of these configurations (FIG. 32D).

In the above-described embodiments, the arms 510 may be configured toengage tissue independently of the deployment of retainer 110. Forexample, delivery catheters suitable for the delivery of the prostheticheart valve devices 100 may be equipped with separate mechanismsoperable to deploy the arms 510 and the retainers 110 individually orotherwise independently of each other. In this way, the retainer 110 maybe first released into engagement with the native tissue so that theposition of device 100 may be assessed and adjusted by the operatoruntil the desired final position has been attained. Following deploymentand positioning of the retainer 110, the arms 510 can be released toengage the tissue. Such deployment systems and methods are useful whenthe arms 510 are equipped with tissue engaging elements 170 which, oncedeployed, may prohibit any repositioning of the device 100. In someembodiments, the retainer 110 will be equipped with atraumatic tissueengagement elements 170 which do not penetrate tissue or inhibit devicerelocation once the retainer 110 has been deployed. Accordingly, someembodiments of the device 100 may be repositionable even with theretainer 110 expanded so long as the arms 510 are constrained in anundeployed configuration, with the device 100 becoming permanentlyanchored only when the arms 510 are released.

Alternatively or in addition to tissue engaging elements 170 present onthe arms 510 as described above, tissue engaging elements 170 may bepresent on other components of the device 100. FIGS. 33A-33E are sideviews of prosthetic heart valve devices 100 having tissue engagingelements 170 on varying structures of the device 100 in accordance withadditional embodiments of the present technology. FIG. 33A shows tissueengaging elements 170 incorporated on the tissue engaging portion 112 ofthe ribs 114 of the retainer 110. FIG. 33B illustrates an embodiment ofthe device 100 having the tissue engaging elements 170 along the struts124 of the valve support 120. Likewise, FIG. 33C shows an embodiment ofthe device 100 having the tissue engaging elements 170 along the postsof the valve support 120. In another embodiment, shown in FIG. 33D, thetissue engaging elements 170 can be incorporated along the surfaces ofseveral device components, such as the ribs 114 as well as the posts 122and struts 124 of the valve support 120.

The tissue engaging elements 170 are shown in FIGS. 33A-33Dschematically, but one of ordinary skill in the art will recognize thatthe elements can be any of a variety of tissue engaging elements 170described herein (e.g., atraumatic, partially piercing, fullypenetrating, etc.), or in other embodiments, a combination of differenttypes of tissue engaging elements 170. Additionally, the tissue engagingelements 170 are shown oriented in an upstream direction (e.g., toinhibit upstream migration of the device 100) in FIGS. 33A-33B; however,in other embodiments, the tissue engaging elements 170 can be orientedin a downstream direction (e.g., to inhibit downstream migration of thedevice 100), or in a combination of downstream and upstream orienteddirections (shown in FIGS. 33C-33D). The tissue engaging elements 170can be incorporated symmetrically around a circumference or outsidesurface of the device 100, or in other embodiments, the tissue engagingelements 170 can be incorporated asymmetrically. For example, in someembodiments, the tissue engaging elements 170 can be present on a sideof the device 100 aligned with the posterior leaflet, but be absent orhave a different arrangement on a side of the device 100 aligned withthe anterior leaflet such that the wall separating the aortic valve fromthe left ventricle will not be affected by the tissue engaging elements170.

FIG. 33E illustrates an embodiment of the device 100 having tissueengaging elements 170, such as spikes on a rib tip 117 of the rib 114,wherein the spikes 174 can be configured to fully or partially penetratesubannular tissue when the device 100 is deployed on or under theannulus of the mitral valve. In some embodiments, the tissue engagingelements 170 (e.g., spikes) can include barbs 176 or other features forretaining the tissue engaging elements 170 (e.g., spikes) in the tissue.In other embodiments, the tissue engaging elements 170 (e.g., spikes)can be blunt so as to engage but not penetrate the subannular tissue.FIGS. 33F-33G are enlarged side views of tissue engaging elements 170(e.g., hooks, spikes, etc.) suitable for use on rib tips 117 of the ribs114. In one embodiment, shown in FIG. 3F, the rib tip 117 may include arounded hook 172 that may partially pierce other fully penetrate cardiactissue at the target location with the retainer 110 is deployed. Inanother embodiment, shown in FIG. 33G, the rib tip 117 may include abarbed protrusion such as a spike 174, 176 for piercing cardiac tissueat the target location.

Alternatively, tissue engaging elements 170, such as bumps, ridges, orother protrusions configured to exert frictional forces on cardiactissue, may be also present on one or more valve support struts 124,valve support posts 122, and/or other components (e.g., sealing members140). These tissue engaging elements 170 can be disposed on an outerportion of these features and can be configured to extend outwardly toengage the native leaflets and to stabilize and firmly anchor the device100 in the desired location. Alternatively, ridges, scales, bristles, orother features having directionality may be formed on the surface of theribs 114 or sealing member 140 to allow movement relative to nativetissue in one direction, while limiting movement in the oppositedirection.

In accordance with another embodiment of the prosthetic treatment device100, tissue engaging elements 170 can be incorporated into sealingmembers 140 (e.g., sleeve 146). FIGS. 34A-34B are an isometric view andan enlarged detail view of a prosthetic heart valve device 100 having asealing member 140 configured with tissue engaging elements 170.Referring to FIGS. 34A-34B together, the tissue engaging elements 170can comprise metallic or polymeric wires 178 or fibers, rigid and sharpenough to penetrate tissue, which are woven into or otherwise coupled tosealing member 140 materials. The sealing member 140 can then beattached to outer and/or inner surfaces 141, 142 of the retainer 110and/or interior and/or exterior surfaces 126, 127 of the valve support120 such that tissue engaging elements 170 extend radially outward fromthe sealing member 140 to engage the adjacent leaflets or other tissue.

FIGS. 35A-35F are enlarged side views of embodiments of additionaltissue engaging elements that can be incorporated on various devicestructures (referred collectively as “ST”), such struts, posts, arms,and/or ribs which may be incorporated into device features, such as theretainer 110 or valve support 120. For example, the additional tissueengaging elements may comprise one or more cut-out protrusions 350(FIGS. 35A and 35B) in place of or in addition to tissue engagingelements 170. In a collapsed or straightened configuration, as shown bythe side view of FIG. 35C, cut-out protrusion 350 maintains low reliefrelative to the surface of structure ST to maintain a low profile duringdelivery. As the device 100 expands and structure ST changes to itsdeployed configuration (e.g. a curvature as shown in FIG. 35D), theprotrusion separates from the ST to a higher relief. The protrusion 350may also be configured to grab subannular tissue, pulling the cut-outprotrusions even farther away from structure ST. The device structuresST may also be shaped to include sharp protrusions 352 along one or moreof its edges or faces, as illustrated in FIG. 35E, or may also includepointed scale-like protrusions 354, as shown in FIG. 35F.

Prosthetic Heart Valve Devices Having Atrial Extension Members

FIG. 36A is an isometric view of a prosthetic heart valve device 100having an atrial extension member 410 in accordance with variousembodiments of the present technology. The atrial extension member 410can be generally cylindrical, being formed around the longitudinal axis101 of the device 100 with a circular, oval, elliptical, kidney-shapedor other suitable cross-section. As shown in FIG. 36A, the atrialextension member 410 can be coupled to the retainer ribs 114, to theposts 122 of the valve support 120, or to some other device component.In one embodiment, the atrial extension member 410 can be formed byextension 411 of the ribs 114 in an upward direction. The atrialextension member 410 can include an upstream portion 412 formed by theextension 411 of the ribs 114 and including interconnecting struts 414and/or other posts which can be arranged in a variety of geometricpatterns (e.g., chevron, diamond, etc.) for support and resilience ofthe atrial extension member 410. The atrial extension member can beconfigured to extend into an intra-annular, supra-annular or atriallocation in the heart to provide additional support to the device 100and/or prevent the device 100 from moving in a downstream or upstreamdirection. A sealing member 140, such as the sleeve 146, can optionallyreside on the inner 420 and/or outer 422 surface of the atrial extensionmember 410.

FIGS. 36B-36C are schematic, top views of an embodiment of a prostheticheart valve device 100 having an atrial extension member 410 without(FIG. 36B) and with (FIG. 36C) a twisting force applied to the device100 in accordance with the present technology. FIG. 36B shows the device100 in the expanded configuration 102 having the atrial extension member410 and a plurality of ribs 114 positioned circumferentially around thedevice 100 to form the retainer 110. FIG. 36B shows the device 100 in adeployed configuration 104 wherein a twisting force Tw is applied to theretainer 110 such that the ribs 114 are flexed, bent and/or rotated withrespect to an outer surface 430 of the device 100 and/or the atrialextension member 410 to conform to the native heart valve tissue (e.g.,mitral valve annulus).

The expandable retainer, valve support, arms, atrial extension may bemade from any number of suitable biocompatible materials, e.g.,stainless steel, nickel-titanium alloys such as Nitinol™, variouspolymers, ELGILOY® (Elgin, Ill.), pyrolytic carbon, silicone,polytetrafluoroethylene (PTFE), or any number of other materials orcombination of materials depending upon the desired results. The armmembers may also be coated or covered with a material that promotestissue in-growth, e.g., Dacron®, PTFE, coatings, etc.

Delivery Systems

FIGS. 37A-37D illustrate one embodiment of a delivery system 10 suitablefor delivery of the prosthetic heart valve devices disclosed herein. Asused in reference to the delivery system, “distal” refers to a positionhaving a distance farther from a handle of the delivery system 10 alongthe longitudinal axis of the system 10, and “proximal” refers to aposition having a distance closer to the handle of the delivery system10 along the longitudinal axis of the system 10.

FIG. 37A illustrates one embodiment of the delivery system 10 which maybe used to deliver and deploy the embodiments of the prosthetic heartvalve device 100 disclosed herein through the vasculature and to theheart of a patient. The delivery system 10 may optionally include aguiding catheter GC having a handle 12 coupled to a delivery shaft 16,which in one embodiment is 34F or less, and in another embodiment, 28For less in diameter. The guiding catheter GC may be steerable orpre-shaped in a configuration suitable for the particular approach tothe target valve. The delivery catheter 18 is placed through ahemostasis valve HV on the proximal end of guiding catheter GC andincludes a flexible tubular outer shaft 19 extending to a deliverysheath 20 in which the device 100 is positioned in a collapsed ordelivery configuration 106. A flexible inner shaft 28 is positionedslideably within outer shaft 19 and extends through the device 100 to anosecone 21 at the distal end. The inner shaft 28 has a guidewire lumenthrough which a guidewire 24 may be slideably positioned. The device 100is coupled to the inner shaft 28 and is releasable from the inner shaft28 by release wires 30, as more fully described below. The deliverysheath 20 can protect and secure the device 100 in its collapsedconfiguration 106 during delivery. The outer shaft 20 is coupled to aretraction mechanism 23 on the handle 14 of the delivery catheter 18.Various retraction mechanisms 23 may be used, such as anaxially-slidable lever, a rotatable rack and pinion gear, or other knownmechanisms. In this way, the outer shaft 20 may be retracted relative tothe inner shaft 28 to release (e.g., deploy) the device 100 from thesheath 20.

FIG. 37B shows the distal end of the delivery catheter 18 with thesheath 20 cut away to illustrate the coupling of the device 100 to theinner shaft 28. A plurality of locking fingers 32 are coupled to thenose cone 21 and extend proximally through the interior of the valvesupport 120 of the device 100. As shown in FIG. 37C, a selected numberof posts 122 of the valve support 120 have a coupling element 61comprising a tab 34 cut out from each post 122 at a proximal endthereof. The tab 34 may be deflected inwardly from the post 122 as shownin FIG. 37B and is configured to extend through a window 42 in thelocking finger 32 as shown in FIG. 37D. The release wires 30 passthrough the holes 40 in the tabs 34, which prevents the tabs 34 frombeing withdrawn from the windows 42 to secure the device 100 to theinner shaft 28. The pull-wires 30 can be sandwiched tightly between thetabs 34 and the locking fingers 32, such that friction temporarilyprevents the pull-wire 30 from slipping in a proximal or distaldirection. In this way, the sheath 20 may be refracted relative to thedevice 100 to permit expansion of the device 100 while the inner shaft28 maintains the longitudinal position of the device 100 relative to theanatomy. The pull-wires 30 may extend proximally to the handle 14, forexample, in between the inner shaft 28 and the outer shaft 19 or withinone or more designated lumens. A suitable mechanism (not shown) on thehandle 14 can allow the operator to retract the release wires 30 in aproximal direction until they are disengaged from the tabs 34.Accordingly, the device 100 can be released from the locking fingers 32and expand for deployment at the target site.

FIGS. 38A-38D are schematic, cross-sectional side views of a heart Hshowing a trans-septal or antegrade approach for delivering anddeploying a prosthetic heart valve device 100. As shown in FIG. 38A, aguidewire 24 may be advanced intravascularly using any number oftechniques, e.g., through the inferior vena cava IVC or superior venacava SVC, through the inter-atrial septum IAS and into the right atriumRA. The guiding catheter GC may be advanced along the guidewire 24 andinto the right atrium RA until reaching the anterior side of the atrialseptum AS, as shown in FIG. 38B. At this point, the guidewire 24 may beexchanged for the needle 25, which is used to penetrate through theinter-atrial septum IAS (FIG. 38C). The guiding catheter GC may then beadvanced over the needle 25 into the left atrium LA, as shown in FIG.38D. The guiding catheter GC may have a pre-shaped or steerable distalend to shape or steer the guiding catheter GC such that it will directthe delivery catheter 18 (FIG. 37A) toward the mitral valve.

As an alternative to the trans-septal approach, the mitral valve mayalso be accessed directly through an incision in the left atrium. Accessto the heart may be obtained through an intercostal incision in thechest without removing ribs, and a guiding catheter may be placed intothe left atrium through an atrial incision sealed with a purse-stringsuture. A delivery catheter may then be advanced through the guidingcatheter to the mitral valve. Alternatively, the delivery catheter maybe placed directly through an atrial incision without the use of aguiding catheter.

FIGS. 39A-39C are cross-sectional views of the heart illustrating amethod of implanting a prosthetic heart valve device 100 using atrans-septal approach. Referring to FIGS. 39A-39C together, the distalend 21 of the delivery catheter 18 may be advanced into proximity to themitral valve MV. Optionally, and as shown in FIG. 39A, a guidewire GWmay be used over which catheter 18 may be slideably advanced over aguidewire GW. The sheath 20 of the delivery catheter 18, which containsthe device 100 in a collapsed configuration 106, is advanced through themitral valve annulus AN between native leaflets LF, as shown in FIG.39A. Referring to FIG. 39B, the sheath 20 is then pulled back proximallyrelative to the distal nose cone 21 allowing the device 100 to expandsuch that retainer 110 pushes the leaflets LF outwardly to fold beneaththe mitral valve annulus AN. After the sheath 20 has been removed andthe device 100 allowed to expand, the delivery system can still beconnected to the device 100 (e.g., system eyelets, not shown, areconnected to the device eyelets) so that the operator can furthercontrol the placement of the device 100 as it expands toward theexpanded configuration 102. For example, the device 100 may be expandedupstream or downstream of the target location then pushed downstream orupstream, respectively, into the desired target location beforereleasing the device 100 from delivery system 10. Once the device 100 ispositioned at the target site, the pull-wires 30 (FIGS. 37A-37B) may berefracted in a proximal direction, to detach the device 100 in thedeployed configuration 104 from the delivery catheter 18. The deliverycatheter 18 can then be removed as shown in FIG. 39C. Alternatively, thedevice 100 may not be connected to the delivery system 10 such that thedevice 100 deploys and is fully released from the delivery system 10.

FIGS. 40A-40C illustrate delivery of the device 100 in the collapsedconfiguration 106 to the mitral valve MV via a trans-apical approach.Referring to FIG. 40A, the delivery catheter 18 is advanced through aguiding catheter GC that has been inserted into the left ventricle ofthe heart through a puncture in the left ventricle wall at or near theapex of the heart. The catheter can be sealed by a purse-string suture.Alternatively, the delivery catheter 18 may be placed directly through apurse-string-sealed trans-apical incision without a guiding catheter.The sheath 20 and the device 100 (e.g., in the collapsed configuration106) within the sheath 20 are advanced through the mitral annulus ANbetween native leaflets LF as shown in FIG. 40A. Referring to FIG. 40B,the sheath 20 is pulled proximally such that the device 100 expands tothe expanded and/or deployed configurations 102, 104. The deliverysystem 10 can remain connected to the device 100 (e.g., system eyelets,not shown, are connected to the device eyelets) after removing thesheath 20 so that the operator can control the placement of the device100 while the device expands toward the expanded configuration 102. Thepull-wires 30 may be retracted in a proximal direction to release thedevice 100 from the delivery system 10, allowing the delivery system 10to be removed and the device to be fully implanted at the mitral valveMV in the deployed configuration 104. In one embodiment, the device 100may be expanded upstream or downstream of the desired target locationthen pulled or pushed downstream or upstream, respectively, into thetarget location before releasing the device 100 from delivery system 10.Alternatively, the device 100 may not be connected to the deliverysystem 10 such that the device 100 deploys and is fully released fromthe delivery system 10.

In another embodiment, not shown, the device 100 can be mounted on anexpandable balloon of a delivery catheter and expanded to its functionalsize by inflation of the balloon. When using a balloon delivery system,the device 100 can be advanced from the delivery shaft to initiallyposition the device in a target location. The balloon can be inflated tofully expand the device 100. The device 100 may then be adjusted usingthe device locking hub to position the device into the desiredimplantation site (e.g., just below the annulus of the native mitralvalve). In another embodiment, the balloon initially can be partiallyinflated to partially expand the valve assembly in the left atrium. Thedelivery system 10 can then be adjusted to push or pull (depending onthe approach) the partially expanded valve into the implantation site,after which the valve assembly can be fully expanded to its functionalsize.

Additional Embodiments

Features of the prosthetic heart valve device components described aboveand illustrated in FIGS. 10A-40C can be modified to form additionalembodiments configured in accordance with the present technology. Forexample, the prosthetic heart valve device 100 illustrated in FIG. 18and other prosthetic heart valve devices described above withoutstabilizing members can include stabilizing members, such as arms thatare coupled to the valve support or other feature and are configured toextend radially outward to engage leaflet tissue. Similarly, any of theprosthetic heart valve devices described above and illustrated in FIGS.10A-40C can include features such as sealing members as well asstabilizing features and tissue engaging elements. Features of theprosthetic heart valve device components described above also can beinterchanged to form additional embodiments of the present technology.

The following Examples are illustrative of several embodiments of thepresent technology.

EXAMPLES

1. A device for repair or replacement of a native heart valve, thenative heart valve having an annulus and leaflets coupled to theannulus, comprising:

-   -   a valve support having an upstream end and a downstream end        extending along a longitudinal axis, the valve support having an        outer surface and an inner surface, wherein the inner surface is        configured to support a prosthetic valve, and wherein the valve        support has a cross-sectional shape;    -   an expandable retainer coupled to the upstream end of the valve        support, the retainer configured to engage tissue on or near the        annulus; and    -   wherein the valve support is mechanically isolated from the        retainer such that the cross-sectional shape of the valve        support remains sufficiently stable when the retainer is        deformed in a non-circular shape by engagement with the tissue.

2. A prosthetic heart valve device for treating a mitral valve,comprising:

-   -   a valve support configured to support a valve;    -   a retainer coupled to the valve support at an upstream end of        the device, wherein the retainer is positionable at least        partially along a subannular surface of a native mitral valve        annulus, and wherein the retainer is configured to inhibit        upstream migration of the device; and    -   wherein the retainer is coupled to the valve support so as to        mechanically isolate the valve support from distorting force        exerted on the retainer by native anatomy.

3. A prosthetic heart valve device for treating a mitral valve,comprising:

-   -   an expandable retainer configured to engage cardiac tissue at or        downstream of a native mitral valve annulus; and    -   a valve support coupled to and extending in a downstream        direction from the expandable retainer, wherein the valve        support is configured to support a prosthetic valve;    -   wherein the expandable retainer is configured to conform to the        shape of the native mitral valve annulus while the valve support        remains substantially unchanged.

4. A prosthetic heart valve device for treating a native heart valve ina patient, comprising:

-   -   a valve support having a generally circular shape and configured        to support a prosthetic valve;    -   a deformable retainer coupled to an upstream portion of the        valve support and configured to engage cardiac tissue on or        below an annulus of the heart valve; and    -   a plurality of arms coupled to a downstream portion of the valve        support, the plurality of arms configured to engage a native        leaflet, wherein the arms are biased outwardly from the valve        support in an unbiased configuration;    -   wherein the valve support is mechanically isolated from the        retainer such that deformation of the retainer does not        substantially affect the generally circular shape of the valve        support.

5. The device of example 1 wherein the retainer is positioned upstreamof an upstream end of the valve support.

6. The device of examples 1 or 4 wherein the retainer is configured toengage valve tissue selected from an inward-facing surface of theannulus and an inward facing surface of the leaflets downstream of theannulus.

7. The device of any one of examples 1-4 wherein the device is moveableinto a plurality of configurations including:

-   -   a first configuration in which the valve support and the        retainer are radially contracted, and wherein the valve support        has a first cross-sectional shape;    -   a second configuration in which the valve support and the        retainer are radially expanded, and wherein the valve support        has a second cross-sectional shape greater than the first        cross-sectional shape; and    -   a third configuration in which the retainer is engaged with and        at least partially deformed by tissue on or near the annulus        while the valve support remains in the second cross-sectional        shape.

8. The device of example 7 wherein the retainer assumes the secondconfiguration in an unbiased condition.

9. The device of example 7 wherein the retainer is deformable from thesecond configuration to the third configuration.

10. The device of example 7 wherein the device in the firstconfiguration has a low profile configured for delivery through a guidecatheter positioned at or near the native heart valve.

11. The device of example 10 wherein the retainer has a first diameterin the second configuration, and wherein the first diameter spans atleast the distance between native commissures of the native heart valve.

12. The device of example 10 wherein the native heart valve is a mitralvalve.

13. The device of example 7 wherein the retainer has an outercircumference, the outer circumference being generally circular in thesecond configuration and generally non-circular in the thirdconfiguration.

14. The device of example 7 wherein the retainer has an innercircumference, the inner circumference defining a passage for blood toflow through the valve support, and wherein the inner circumference issubstantially circular in the third configuration.

15. The device of any one of examples 1-3 wherein the valve support isgenerally circular and the retainer is deformable to be generallynon-circular when engaging the tissue.

16. The device of any one of examples 1-3 wherein the retainer includesa plurality of flexible ribs extending outward from the valve supportand in an upstream direction, the ribs being distributed around aperimeter of the valve support.

17. The device of example 16 wherein the ribs are non-symmetricallydistributed around the perimeter.

18. The device of example 16 wherein the ribs are symmetricallydistributed around the perimeter.

19. The device of example 16 wherein the retainer includes betweenapproximately 2 and about 30 ribs.

20. The device of example 16 wherein the retainer includes betweenapproximately 6 and about 20 ribs.

21. The device of example 16 wherein the flexible ribs are arcuate ribs.

22. The device of example 21 wherein the arcuate ribs have rib tips thatare oriented inwardly toward the longitudinal axis.

23. The device of any one of examples 1-4 wherein the retainer has across-sectional dimension greater than a corresponding cross-sectionaldimension of the annulus of the native heart valve.

24. The device of any one of examples 1-4, further comprising a sealingmember disposed on a surface of the retainer and configured to sealagainst at least the tissue on or near the annulus to inhibit blood flowbetween the retainer and the tissue.

25. The device of example 24 wherein the sealing member further extendsaround at least one of the inner surface or the outer surface of thevalve support, and wherein the sealing member is configured to inhibitblood flow in a space between the valve support and the retainer.

26. The device of example 24, further comprising a plurality of piercingelements coupled to the sealing member for piercing the tissue.

27. The device of any one of examples 1-4 wherein the valve supportincludes a plurality of posts connected circumferentially by a pluralityof struts, and wherein the retainer includes a plurality of arcuate ribsextending outward from the valve support and in an upstream direction,the ribs being distributed about a perimeter of the valve support.

28. The device of example 27 wherein the ribs are integral with theposts.

29. The device of example 27 wherein the ribs are coupled to at leastone of the posts and the struts.

30. The device of example 27 wherein the individual ribs are coupled tothe posts with a fastener.

31. The device of example 27 wherein the ribs are coupled to the postswith a hypotube.

32. The device of example 27 wherein the ribs are welded or bonded tothe posts.

33. The device of example 1 wherein the retainer includes a plurality offlexible ribs extending outward and in an upstream direction, andwherein the plurality of flexible ribs are at least partially covered bya sealing member.

34. The device of example 33 wherein the sealing member comprises one ormore of a polymer, thermoplastic polymer, a polyester, a syntheticfiber, a fiber, polyethylene terephthalate (PET), expandedpolytetrafluoroethylene (ePTFE), Dacron® or bovine pericardial tissue.

35. The device of example 33 wherein the sealing member promotes tissueingrowth into the sealing member.

36. The device of example 1, further comprising a sealing memberdisposed around an outer surface of the retainer, the sealing memberconfigured to seal against the tissue to inhibit blood flow between theretainer and the tissue.

37. The device of example 1 wherein the retainer includes a plurality offlexible C-shaped ribs circumferentially positioned around an upperportion of the device, and wherein the retainer is a donut-shaped flangecoupled to the upstream end of the valve support.

38. The device of example 37 wherein the C-shaped ribs have a firstradius of curvature in an unbiased state, and wherein the C-shaped ribsare configured to be deformed in a deployed configuration such that theC-shaped ribs have a second radius of curvature, the second radius ofcurvature being smaller or greater than the first radius of curvature.

39. The device of example 37 wherein deformation of any one of theplurality of C-shaped ribs does not substantially deform the valvesupport.

40. The device of example 1 wherein:

-   -   the retainer includes a plurality of flexible ribs        circumferentially positioned around the valve support;    -   each individual rib includes a plurality of rib segments; and    -   each rib segment has a characteristic different than another rib        segment, the characteristic being selected from shape, length,        profile, flexibility and orientation with respect to the        longitudinal axis.

41. The device of example 40 wherein each rib segment has a segmentshape selected from one of linear, curved, coiled, or angled.

42. The device of example 1 wherein the retainer includes a plurality offlexible ribs extending outward from the valve support and in anupstream direction, and wherein each individual rib has a characteristicdifferent than another rib, the characteristic being selected fromshape, height, axial strength, flexibility and orientation with respectto the longitudinal axis.

43. The device of example 1 wherein the retainer includes a plurality offlexible ribs extending outward from the valve support and in anupstream direction, and wherein ribs include a rib tip, and wherein therib tip includes a hook, a barb or an atraumatic surface.

44. The device of example 1 wherein the retainer includes a plurality ofcurved ribs extending outward from the valve support and in an upstreamdirection, and wherein one or more ribs are deformed to modify a shapeof the retainer from a generally circular shape to a generallynon-circular shape in a deployed configuration.

45. The device of example 1 wherein the retainer includes a plurality offlexible ribs distributed around a perimeter of the valve support, andwherein one or more ribs bends or rotates in the deployed configuration.

46. The device of example 1 wherein the retainer includes a plurality offlexible ribs distributed around a perimeter of the valve support, andwherein each of the plurality of flexible ribs has a column strengthsufficient to inhibit movement of the device relative to the annulusunder the force of systolic blood pressure against a valve mounted inthe valve support.

47. The device of example 1 wherein the retainer includes a plurality offlexible ribs distributed around a perimeter of the valve support, andwherein the flexible ribs are configured to absorb distorting diastolicand systolic forces generated in the heart having the native heartvalve.

48. The device of any one of examples 1-4 wherein the retainer isself-expanding.

49. The device of any one of examples 1-4 wherein the retainer comprisesnitinol.

50. The device of example 1 wherein:

-   -   the tissue on or near the annulus has a generally non-circular        shape having a minor diameter and a major diameter generally        transverse to the minor diameter;    -   the retainer has an outer perimeter having a major perimeter        diameter and a minor perimeter diameter transverse to the major        perimeter diameter while the retainer is engaged with and at        least partially deformed by the tissue on or near the annulus;    -   the major perimeter diameter is greater than the major diameter;        and    -   the minor perimeter diameter is greater than the minor diameter.

51. The device of example 50 wherein the retainer has an outercircumference having a diameter greater than the minor diameter whilethe retainer is in an expanded and unbiased configuration.

52. The device of example 50 wherein the retainer is biased toward anexpanded configuration, and wherein the retainer exerts axial forceagainst the tissue when the retainer is engaged with and at leastpartially deformed by the tissue on or near the annulus.

53. The device of example 1 wherein the device does not engagesupra-annular tissue or tissue upstream of the annulus.

54. The device of example 1 wherein the valve support includes aplurality of posts connected circumferentially by a plurality of struts,and wherein the posts and struts are formed in a chevron configuration.

55. The device of any one of examples 1-4 wherein at least one of theretainer and the valve support comprises a nitinol mesh.

56. The device of any one of examples 1-4 wherein at least one of theretainer and the valve support comprise a shape memory material.

57. The device of any one of examples 1-4 wherein:

-   -   the valve support includes a plurality of posts connected        circumferentially by a plurality of struts;    -   the retainer includes a plurality of flexible ribs coupled to        the posts; and    -   the posts are more rigid than the ribs.

58. The device of example 57, further comprising a connecting ringcoupled to the posts at the downstream end of the valve support.

59. The device of example 57, further comprising a support ring engagingthe plurality of flexible ribs for providing circumferential support tothe retainer.

60. The device of any one of examples 1-4, further comprising aplurality of tissue engaging elements on at least one of the retainer orthe valve support, wherein the tissue engaging elements are configuredto engage tissue on or near the annulus.

61. The device of example 60 wherein the tissue engaging elements areone of barbs, hooks or spikes.

62. The device of example 1 wherein the retainer includes an expandablemesh coupled to the upstream end of the valve support, and wherein theexpandable mesh is configured to evert to form the retainer having afirst cross-sectional dimension greater than a second cross-sectionaldimension of the valve support.

63. The device of example 1 wherein the retainer includes an expandablemesh coupled to the upstream end of the valve support, and wherein theexpandable mesh is configured to roll to form the retainer having afirst cross-sectional dimension greater than a second cross-sectionaldimension of the valve support.

64. The device of example 1, further comprising one or more stabilizingmembers to inhibit movement of the device in an upstream direction,downstream direction, or lateral direction.

65. The device of example 1, further comprising a plurality of armscoupled to the valve support and configured to receive the leafletsbetween the arms and the outer surface.

66. The device of example 65 wherein the arms engage a subannularsurface of the annulus.

67. The device of example 1, further comprising a plurality of armscoupled to the valve support and configured to engage an inward-facingsurface of the leaflets downstream of the annulus.

68. The device of example 67 wherein the arms include one or more tissueengaging elements for penetrating the inward-facing surface of theleaflets.

69. The device of examples 65 or 67 wherein the plurality of arms areconfigured to inhibit movement of the device toward an atrium byengagement of the annulus or the leaflets downstream of the annulus.

70. The device of examples 65 or 67 wherein the plurality of arms aremoveable from an inward configuration for delivery of the device throughvasculature of a patient to an outward configuration for engagement ofthe tissue on or near the annulus.

71. The device of example 65 wherein the arms include arm extensions forengaging the retainer.

72. The device of example 65 wherein the arms are integrally formed withthe valve support.

73. The device of example 65 wherein one or more arms are connected withone or more laterally oriented arm struts.

74. The device of example 1, further comprising an atrial retainerconfigured to engage a supra-annular surface of the annulus or atrialtissue such that downstream movement of the device is blocked byengagement of the atrial retainer with the supra-annular surface or theatrial tissue.

75. The device of any one of examples 1-4, further comprising a valvecoupled to the valve support to inhibit retrograde blood flow.

76. The device of example 75 wherein the valve is a tri-leaflet valve.

77. The device of example 75 wherein the valve is bi-leaflet valve.

78. The device of example 75 wherein the valve comprises bovinepericardium.

79. The device of example 75 wherein a plurality of commissuralattachment structures couple the valve to the interior surface of thevalve support.

80. The device of any one of examples 1-4, further comprising atemporary valve coupled to the valve support, wherein the valve supportis further configured to receive a replacement valve after the device isimplanted at the native heart valve.

81. The device of example 80 wherein the temporary valve is adapted tobe displaced against the inner surface of the valve support when thereplacement valve is received in the valve support.

82. The device of example 80 wherein the temporary valve comprises aremovable valve, and wherein the replacement valve is secured within thevalve support after the temporary valve has been removed.

83. The device of examples 2 or 3, further comprising an atrialextension member extending from the retainer to a position at leastpartially upstream of the native mitral annulus.

84. A method for replacement of a native heart valve having an annulusand a plurality of leaflets, the method comprising:

-   -   positioning a prosthetic device between the leaflets in a        collapsed configuration;    -   allowing the prosthetic device to expand such that a retainer of        the prosthetic device is in a subannular position in which it        engages tissue on or below the annulus, wherein the retainer has        a diameter larger than a corresponding diameter of the annulus        in the subannular position; and    -   allowing a valve support to expand, the valve support being        coupled to the retainer at an upstream end of the valve support;    -   wherein the valve support is mechanically isolated from the        retainer such that deformation of the retainer when engaging the        tissue does not substantially deform the valve support.

85. The method of example 84 wherein the prosthetic device comprises thedevice of any one of examples 1-83.

86. The method of example 84, further comprising delivering the deviceby catheter prior to positioning the prosthetic device between theleaflets.

87. The method of example 86, further comprising retracting a sheath onthe catheter to expose the device in an expanded configuration, andmoving the device in an upstream direction such that the upstreamportion of the retainer engages the tissue.

88. The method of example 86, further comprising navigating the catheterconfigured to retain the device in a delivery configuration by one ormore of a trans-septal approach from a right atrium, a trans-apicalapproach via a left ventricular incision or puncture, or a trans-aorticapproach through the aorta.

89. A method of treating a mitral valve of a patient, the mitral valvehaving an annulus and leaflets, the method comprising:

-   -   implanting a device within or adjacent to the annulus, the        device comprising a valve support and a deformable retainer        coupled to an upstream end of the valve support, wherein at        least the retainer is disposed between the leaflets, and wherein        the retainer is configured to engage tissue on or near the        annulus to prevent migration of the device in an upstream        direction; and    -   wherein the valve support is mechanically isolated from the        retainer such that a cross-sectional shape of the valve support        does not substantially change if the retainer is deformed by        engagement with the tissue.

90. The method of example 89, wherein implanting the device comprises:

-   -   positioning the device between the leaflets and downstream of        the annulus when the device is in a delivery configuration;    -   expanding the device from the delivery configuration to an        expanded configuration with the retainer extending between the        leaflets; and    -   moving the device in an upstream direction to engage the tissue        on or downstream of the annulus with the retainer.

91. The method of example 89, further comprising radially expanding thevalve support after the retainer engages the tissue on or downstream ofthe annulus.

92. The method of example 89 wherein the device is the device of anyoneof examples 1-83.

93. The method of example 89, further comprising delivering the deviceby catheter prior to implantation at the mitral valve.

94. The method of example 93, further comprising retracting a sheath onthe catheter to expose the device in an expanded configuration, andmoving the device in an upstream direction such that the retainerengages subannular tissue.

95. The method of example 89, further comprising navigating a catheterconfigured to retain the device in a delivery configuration by one ormore of a trans-septal approach from a right atrium, a trans-apicalapproach via a left ventricular incision or puncture, or a trans-aorticapproach through an aorta.

96. The method of example 89, further comprising engaging one or morestabilizing members coupled to the valve support with native tissue.

97. A system to treat a mitral valve of a patient, the mitral valvehaving an annulus, the system comprising:

-   -   a device comprising the device of any one of examples 1-83; and    -   a catheter having a lumen configured to retain the device        therein.

98. The system of example 97, further comprising a replacement valveconfigured to couple to the device after placement of the device at themitral valve.

99. The system of example 98, further comprising a delivery cathetercoupled to the replacement valve.

100. The system of example 99 wherein the catheter comprises anexpandable member configured to radially expand portions of the device.

101. The system of example 99 wherein the catheter comprises aretractable sheath, the device being contained within the sheath, andwherein the device is configured to self-expand when the sheath isretracted.

102. The system of example 99 wherein the catheter comprises a guidewirelumen adapted to slideably receive a guidewire, the guidewire lumenhaving proximal and distal ports through which the guidewire may beslideably inserted.

CONCLUSION

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of thetechnology, as those skilled in the relevant art will recognize. Forexample, while steps are presented in a given order, alternativeembodiments may perform steps in a different order. The variousembodiments described herein may also be combined to provide furtherembodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

We claim:
 1. A method for replacement of a native mitral valve having anannulus and a plurality of leaflets, the method comprising: positioninga prosthetic device between the plurality of leaflets in a collapsedconfiguration; allowing the prosthetic device to expand such that aretainer of the prosthetic device is in a subannular position betweenthe plurality of leaflets in which the retainer engages tissue on ordownstream of the annulus, wherein the retainer forms a ring having adiameter larger than a corresponding diameter of the annulus in thesubannular position; and allowing a valve support to expand, at least aportion of the retainer being positioned at an upstream end of the valvesupport; wherein the upstream end of the valve support is radiallyinward from and longitudinally overlapping a portion of the retainerwhen the prosthetic device is in a deployed configuration; and whereinthe valve support is mechanically isolated from the retainer such thatradial deformation of the retainer when engaging the tissue does notsubstantially deform the valve support.
 2. The method of claim 1,further comprising delivering the prosthetic device by a catheter priorto positioning the prosthetic device between the plurality of leaflets.3. The method of claim 2, further comprising retracting a sheath on thecatheter to expose the prosthetic device in an expanded configuration,and moving the prosthetic device in an upstream direction such that anupstream portion of the retainer engages the tissue.
 4. The method ofclaim 2, further comprising navigating the catheter configured to retainthe device in a delivery configuration by one or more of a trans-septalapproach from a right atrium, a trans-apical approach via a leftventricular incision or puncture, or a trans-aortic approach through theaorta.
 5. The method of claim 1 further comprising engaging tissuearound a circumference of the prosthetic device with a sealing membercovering the retainer to inhibit blood flow between the retainer and thetissue.
 6. The method of claim 1 wherein the valve support ismechanically isolated from the retainer such that a cross-sectionalshape of the valve support remains substantially cylindrical if theretainer is radially deformed into a non-circular shape by engagementwith the tissue.
 7. A method of treating a mitral valve of a patient,the mitral valve having an annulus and leaflets, the method comprising:implanting a device within or adjacent to the annulus, the devicecomprising a valve support and an expandable ring-shaped retainerpositioned at an upstream end of the valve support, wherein at least theretainer is disposed between the leaflets, and wherein the retainer isconfigured to engage and seal with tissue on or near the annulus toprevent migration of the device in an upstream direction; wherein theupstream end of the valve support is radially inward from andlongitudinally overlapping a portion of the retainer when the device isin a deployed configuration; and wherein the valve support ismechanically isolated from the retainer such that a cross-sectionalshape of the valve support remains substantially cylindrical if theretainer is radially deformed into a non-circular shape by engagementwith the tissue.
 8. The method of claim 7, wherein implanting the devicecomprises: positioning the device between the leaflets and downstream ofthe annulus when the device is in a delivery configuration; expandingthe device from the delivery configuration to an expanded configurationwith the retainer extending between the leaflets; and moving the devicein an upstream direction to engage the tissue on or downstream of theannulus with the retainer.
 9. The method of claim 7, further comprisingradially expanding the valve support after the retainer engages thetissue on or downstream of the annulus.
 10. The method of claim 7,further comprising delivering the device by a catheter prior toimplantation at the mitral valve.
 11. The method of claim 10, furthercomprising retracting a sheath on the catheter to expose the device inan expanded configuration, and moving the device in an upstreamdirection such that the retainer engages subannular tissue.
 12. Themethod of claim 7, further comprising navigating a catheter configuredto retain the device in a delivery configuration by one or more of atrans-septal approach from a right atrium, a trans-apical approach via aleft ventricular incision or puncture, or a trans-aortic approachthrough an aorta.
 13. The method of claim 7, further comprising engagingone or more stabilizing members coupled to the valve support with nativetissue.
 14. A method of treating a heart valve of a patient, the heartvalve having an annulus and leaflets, the method comprising: positioninga prosthetic heart valve device between the leaflets and downstream ofthe annulus when the prosthetic heart valve device is in a deliveryconfiguration, the prosthetic heart valve device comprising: anexpandable valve support having an inflow end and an outflow endextending along a longitudinal axis, the expandable valve support havingan outer surface and an inner surface, wherein the inner surface isconfigured to support a prosthetic valve, and wherein the expandablevalve support has a cross-sectional shape; an expandable retainercoupled to and encircling the expandable valve support, the expandableretainer configured to engage and seal with tissue on or near theannulus on an inner or inflow side of the annulus or the leaflets;wherein the inflow end of the expandable valve support is radiallyinward from and longitudinally overlapping a portion of the expandableretainer when the prosthetic heart valve device is in a deployedconfiguration; and wherein the expandable valve support is mechanicallyisolated from the expandable retainer such that the cross-sectionalshape of the expandable valve support remains substantially cylindricalsuch that the prosthetic valve remains competent when the expandableretainer is deformed into a non-circular shape by engagement with thetissue; expanding the prosthetic heart valve device from the deliveryconfiguration to an expanded configuration with the expandable retainerextending between the leaflets; and moving the prosthetic heart valvedevice in an upstream direction to engage the tissue on or downstream ofthe annulus with the expandable retainer.